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Colloids versus crystalloids for fluid resuscitation in critically ill patients

  1. Pablo Perel*,
  2. Ian Roberts,
  3. Katharine Ker

Editorial Group: Cochrane Injuries Group

Published Online: 28 FEB 2013

Assessed as up-to-date: 17 OCT 2012

DOI: 10.1002/14651858.CD000567.pub6


How to Cite

Perel P, Roberts I, Ker K. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD000567. DOI: 10.1002/14651858.CD000567.pub6.

Author Information

  1. London School of Hygiene & Tropical Medicine, Cochrane Injuries Group, London, UK

*Pablo Perel, Cochrane Injuries Group, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. pablo.perel@Lshtm.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by study ID]
Boldt 1986

MethodsRCT, using sealed opaque envelopes
Information on allocation concealment was obtained on contact with the authors
Blinding and loss to follow-up not mentioned


Participants55 patients undergoing elective aorta-coronary bypass surgery
Exclusion criteria: ejection fraction < 50% and LVEDP > 15 mmHg


Interventions
  1. 300 mL 20% Human albumin solution (n = 15)
  2. 500 mL 3% HES (n = 13)
  3. 500 mL 3.5% Gelatin (n = 14)
  4. No colloid (n = 13)


OutcomesHaemodynamic variables were measured
Deaths not reported


NotesFollow-up until discharge from ICU


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Boldt 1993

MethodsRCT, allocation concealment by sealed opaque envelopes (information from author)
Blinding and loss to follow-up not mentioned


Participants75 males undergoing elective aortocoronary bypass grafting, who had a pulmonary capillary WP < 5 mmHg after induction of anaesthesia


Interventions
  1. 5% Albumin (n = 15)
  2. 6% HES, mean molecular weight 450,000 (n = 15)
  3. 6% HES, mean molecular weight 200,000 (n = 15)
  4. 3.5% Gelatin (n = 15)
  5. No colloid (n = 15)


Fluid used through operation and on intensive care postoperatively


OutcomesDeaths not reported, author confirmed there were no deaths


NotesFollow-up to 1 day


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Boldt 2001

MethodsRCT, using a closed-envelope system


Participants100 patients undergoing major abdominal surgery


Interventions
  1. Ringer's lactate (n = 25)
  2. 6% HES, mean molecular weight 200 kDa, degree of substitution 0.5 (n = 25)
  3. 6% HES, mean molecular weight 130 kDa, degree of substitution 0.4 (n = 25)
  4. 4% Modified fluid gelatin, molecular weight 35 kDa (n = 25)


OutcomesDeaths
Orthostatic problems
Haemodynamics and laboratory data
Fluid input and output
Costs


NotesFollow-up period unclear


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Boutros 1979

MethodsRCT ("randomly divided"), method of allocation concealment not described
Blinding not mentioned
No loss to follow-up


Participants24 people undergoing major operative procedures on the abdominal aorta


Interventions
  1. Albumin in 5% dextrose (n = 7)
  2. 5% Dextrose and Ringer's lactate (n = 8)
  3. 5% Dextrose in 0.45% saline (n = 9)


Allocated fluids were used on admission to ICU, following surgery, guided by PAWP. Whole blood also given if clinically needed


OutcomesDeaths reported


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Bowser-Wallace 1986

MethodsQuasi-RCT, allocation by alternation
Blinding not mentioned
No loss to follow-up


ParticipantsAdmitted for burns of 30% or more
Age range 5 months to 21 years
Excluded if already given more than half calculated daily requirement before reaching hospital


Interventions
  1. 2 mL/kg/%burn Ringer's lactate over 24 hours, then 0.5 mL plasmanate/kg/%burn over 24 hours plus 5% dextrose (n = 19)
  2. 2 mL/kg/%burn hypertonic lactated saline over 24 hours, then 0.6 mL/kg/%burn hypertonic lactated saline over 24 hours plus oral Haldane's solution (n = 19)


IV fluids stopped at 48 hours (n = 19)


OutcomesDeaths reported
Fluid and electrolytes given, weight, haematocrit


NotesFollow-up to 5 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Brunkhorst 2008

MethodsMulticentre, RCT

Blinding not mentioned

Use of a 2 x 2 factorial, open label study design


ParticipantsCritically ill patients with severe sepsis or septic shock of at least 18 years of age. Excluded if onset of symptoms commenced > 24 hours before admission to the ICU, if the symptoms commenced > 12 hours after onset in the ICU or if patient had received more than 1000 mL of HES in the 24 hours before randomisation


Interventions


OutcomesDeaths reported at 28 and 90 days. 90-day mortality rate was cited as it marked the end of the follow-up period


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Bulger 2011

MethodsDouble-blind RCT


Participants15 years or older with hypovolaemic shock (< 70 mmHg SBP or SBP 71 mmHg to < 90 mmHg and HR < 108 bpm


Interventions
  1. 7.5% saline per 6% dextran (n = 220)
  2. 0.9% saline (n = 376)


OutcomesPrimary outcome: 28-day survival

Secondary outcomes: fluid and blood requirements, ARDS, MODS and nosocomial infections


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAll care providers, investigators and patients remained blinded to the treatment assignment

Chavez-Negrete 1991

MethodsRCT, allocation by "random numbers"
Blinding not mentioned
No loss to follow-up


ParticipantsAdults admitted to an emergency department with acute GI haemorrhage, SBP ≤ 90 mmHg for up to 1 hour and normal ECG
Excluded if pregnant or had renal, cardiac or neurological disease


Interventions
  1. Initial infusion of 250 mL 7.5% saline/6% dextran 60 given IV (16 patients) or intraosseous (n = 10)
  2. Initial IV infusion of 250 mL Ringer's lactate (n = 23)


Resuscitation continued with red cells, 0.9% saline and dextran 40 according to clinical judgement


OutcomesDeath
Haemodynamic variables


NotesFollow-up to 24 hours


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Cifra 2003

MethodsQuasi-RCT (allocation by alternation), allocation concealment not reported
Blinding not reported
No loss to follow-up


Participants27 children with dengue shock syndrome
Exclusion criteria included: other severe infection, protein-deficient abnormalities, bleeding diathesis, patients who have been given multiple plasma substitutes


Interventions
  1. 6% Haes-Steril (n = 11)
  2. Ringer's lactate (n = 16)


1 patient from group 1 and 3 patients from group 2 were excluded because they needed inotropic support and multiple plasma substitute


OutcomesDuration of control of shock
Recurrence of shock
Length of ICU stay
Death not reported as an outcome but they reported that 4 patients died


NotesLength of follow-up not reported but all outcomes were in hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskNot used

Cooper 2006

MethodsMulticentre unblinded controlled trial with stratified block randomisation by centre and mortality prediction at enrolment


ParticipantsPatients with cutaneous thermal burns of at least 20% TBSA within 12 hours of injury


Interventions
  1. Ringer lactate and 5% albumin (n = 19)
  2. Ringer lactate (n = 23)


OutcomesPrimary outcome was MODS

Mortality was reported


NotesThe trial was suspended due to slow enrolment


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskPatients were allocated to study groups with stratified randomisation with a computer-generated randomisation list and sequentially numbered sealed, opaque envelopes

Dawidson 1991

MethodsRCT, allocation by drawing a card from a deck
Blinding not mentioned
No loss to follow-up


ParticipantsAdults undergoing elective abdominal aortic surgery
No exclusions mentioned


Interventions
  1. 3% Dextran 70 in Ringer's lactate (n = 10)
  2. IV Ringer's lactate (n = 10)


Fluid used during and for 24 hours after operation, guided by haemodynamic variables


OutcomesDeath
Volume transfused, weight change, haemodynamic variables


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Dehne 2001

MethodsRCT, allocation by sealed envelope assignment


Participants60 male patients (of ASA physical status 1 or 2) scheduled for middle ear surgery


Interventions
  1. Ringer's lactate solution (n = 15)
  2. 6% HES: molecular weight 200 kDa, degree of substitution 0.5 (n = 15)
  3. 6% HES: molecular weight 200 kDa, degree of substitution 0.60 to 0.66 (n = 15)
  4. 6% HES: molecular weight 450 kDa, degree of substitution 0.7 (n = 15)


OutcomesDeaths not stated but 'all' patients discharged 10 to 14 days after surgery; therefore no deaths
Central venous pressure
Urine output
Blood osmolality
Urine osmolality


NotesFollow-up 2 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Du 2011

MethodsRandomised controlled study


ParticipantsParticipants had confirmed diagnosis of severe acute pancreatitis. Patients were included within 72 hours after the onset of symptoms


Interventions
  1. 6% HES 130/0.4 (n = 20)
  2. Ringer's lactate (n = 21)


OutcomesPrimary outcome was intra-abdominal pressure. They also reported in-hospital mortality, organ complications, inflammatory markers and fluid requirement


NotesPatients were excluded if they died within 72 hours after admission


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Dubin 2010

MethodsRCT


ParticipantsPatients with severe sepsis


Interventions
  1. 6% HES 130/0.4 (n = 12)
  2. Normal saline (n = 13)


OutcomesSublingual microcirculation


NotesData on mortality are not clear from the report


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear risksealed enveloped were used

Eleftheriadis 1995

MethodsPatients "randomizedly distributed"
Blinding not mentioned
Unable to assess loss to follow-up


ParticipantsParticipants were undergoing coronary artery bypass surgery


Interventions
  1. 6% HES
  2. 3.5% Gelatin
  3. Ringer's lactate


Allocated fluid was used in the postoperative period only guided by mean arterial pressure


OutcomesDeaths were not reported
Haemodynamic variables


NotesFollow-up period unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Ernest 1999

MethodsRCT, allocation concealment not described
No blinding
No loss to follow-up mentioned


ParticipantsPatients with a clinical diagnosis of sepsis


Interventions
  1. 5% Albumin (n = 9)
  2. 0.9% Saline (n = 9)


Volume of infusion guided by PAWP


OutcomesHaemodynamic variables and volume measurements
Deaths not reported


NotesFollow-up to immediately after infusion


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Evans 1996

MethodsQuasi-randomised trial, allocation by day of the week
Blinding not mentioned
No loss to follow-up


ParticipantsAged ≥ 16 years, admitted with trauma to an emergency centre within 2 hours after injury, only crystalloid as a pre-hospital infusion
Excluded if had underlying illness likely to affect clotting


Interventions
  1. IV Haemaccel (n = 11)
  2. IV Ringer's lactate (n = 14)


Fluid was used until vital signs were stable


OutcomesDeaths from author
Clotting variables


NotesFollow-up period unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Evans 2003

MethodsRCT, allocation concealment not reported
Blinding methods not reported
Loss to follow-up not reported


Participants55 patients undergoing primary unilateral total hip replacement
Exclusion criteria: pre-existing defect in platelet function or on aspirin that could not be stopped for 2 weeks prior to the operation


Interventions
  1. 4.5% Albumin (n = 13)
  2. Gelofusine (n = 14)
  3. Haemaccel (n = 14)
  4. 0.9% Saline (n = 14)


OutcomesHaemostatic parameters
Death not reported


NotesLength of follow-up not reported but all outcomes were in-hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Fries 2004

MethodsRCT, patients "randomly" received crystalloid or colloids
Method of allocation concealment not reported
Blinding not reported
Loss to follow-up not reported


Participants60 patients undergoing knee replacement surgery
Exclusion criteria: contraindication for regional anaesthesia, known allergies or haemostatic disorders


Interventions
  1. HES (n = 20)
  2. Modified gelatin (n = 20)
  3. Ringer's solution (n = 20)


Groups 1 and 2 also received a basis of Ringer's solution infusion


OutcomesCoagulation parameters
Death not reported


NotesLength of follow-up not reported but all outcomes were in-hospital measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Gallagher 1985

MethodsRCT, method of allocation concealment not described. Author contacted - allocation concealment by computerised system - patient details were entered before treatment assignment was revealed
Blinding not mentioned
No loss to follow-up


ParticipantsPatients after coronary artery bypass graft surgery
Exclusion criteria: patients with significant left main coronary artery stenosis, poor left ventricular function or poor pulmonary function


Interventions
  1. IV 5% albumin (n = 5)
  2. IV 6% HES (n = 5)
  3. IV Ringer's lactate (n = 5)


Fluid used from admission to ICU post operation, guided by PAWP. RBC given if needed


OutcomesDeaths were not reported. Author contacted and confirmed that there were no deaths in any group
Haemodynamic data


NotesFollow-up to 1 day


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Goodwin 1983

MethodsRCT, assigned by "random numbers table", method of allocation concealment unclear
Blinding not mentioned
No loss to follow-up


Participants79 previously healthy young adults admitted with burns
No exclusion criteria reported


Interventions
  1. 2.5% Albumin in Ringer's lactate (n = 40)
  2. Ringer's lactate (n = 39)


Fluids on day 1 guided by haemodynamic variable. On day 2, given at 0.3 to 0.5 mL/kg/%burn, then 5% dextrose


OutcomesDeaths reported
Pulmonary oedema

Infections


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Grundmann 1982

MethodsRCT, method of allocation concealment unclear
Blinding not mentioned
No loss to follow-up


Participants20 people undergoing partial gastrectomy
The average age was 50 years (range 19 to 84 years)
No exclusion criteria reported


Interventions
  1. Colloid group received human albumin solution (n = 14)
  2. Details of crystalloid were not reported (n = 6)


Allocated fluid was continued for 4 days after operation


OutcomesDeaths reported
Volumes of fluid given
Haemodynamic variables


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Guidet 2012

MethodsRCT

Double blind

Sequence generation not reported

Two arms were identical in appearance, labelled with randomisation numbers

1 outcome from each group missing at day 90


Participants196 patients aged ≥18 years, who required fluid resuscitation, and who had clinically defined severe sepsis

Exclusion criteria: Known serum creatinine >3.39 mg/d, Anuria lasting more than 8 hours despite fluid resuscitation, Requirement for renal support

Setting: Germany and France


Interventions1. 6% HES 130/0.4 (n=100)

2. sodium chloride (NaCl 0.9%) (n=96)


OutcomesThe primary endpoint was the amount of study drug required to achieve initial HDS The secondary objectives were time taken to achieve initial HDS, total quantity of study drug infused, length of stay (LOS) in the ICU, Sequential Organ Failure Assessment (SOFA) score and kidney function


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskThe investigational and control drugs were identical in appearance and packaging, and were labeled with randomization numbers using a blinding methodology

Guo 2003

MethodsRCT, allocation concealment not reported
Blinding not reported
No loss to follow-up reported


Participants42 patients undergoing elective cytoreductive surgery for ovarian cancer
Exclusion criteria: preoperative anaemia, allergic response to HES or perioperative administration of cardiovascular agents
2 patients randomised but excluded because of use of cardiovascular agents


Interventions
  1. Ringer's lactate (n = 20)
  2. 6% HES (n = 20)


OutcomesSplanchnic perfusion
Death not reported but in results authors mentioned that "all patients were discharged"


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Hall 1978

MethodsQuasi-RCT (participants were stratified by age, extent of burn and aetiology, and then allocated by alternation)
Blinding not mentioned
No loss to follow-up


ParticipantsBurns covering > 10% of the body surface (for children), and > 15% of the body surface (for adults)
No exclusions mentioned


Interventions
  1. 120 mL/%burn IV 6% dextran 70 in 0.9% saline over 48 hours plus oral water or IV 5% dextrose for 'metabolic requirements' (n = 86)
  2. 4 mL/kg/%burn IV Ringer's lactate over 24 hours, then 10% of initial body weight of fluid over 24 hours plus oral water (n = 86)


OutcomesDeath
Fluid given, haemodynamic variables


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Hartmann 1993

MethodsRCT, method of allocation unclear
Blinding not mentioned
No loss to follow-up


ParticipantsAdults undergoing major abdominal surgery
Exclusion criteria: cardiorespiratory dysfunction, uraemia, diabetes, taking steroids, anticoagulants or diuretics


Interventions
  1. IV Dextran 70 in saline (concentration not given) with 2.5% dextrose (n = 15)
  2. IV Saline (concentration not given) with 2.5% dextrose (n = 14)


Both groups given red cells, plasma, dextran 70 and crystalloids during the operation as decided by the clinician. Postoperative fluids according to the trial group guided by tissue oxygen tension to the end of resuscitation


OutcomesDeath not reported
Fluid given, haemodynamic variables


NotesFollow-up to 7 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

James 2011

MethodsRCT

Double-blind


ParticipantsPatients with blunt or penetrating trauma requiring more than 3 L volume resuscitation (blunt and penetrating trauma patients were randomised separately)


Interventions
  1. HES 130/0.4, penetrating trauma (n = 36)
  2. 0.9% Saline, penetrating trauma (n = 34)
  3. HES 130/0.4, blunt trauma (n = 22)
  4. 0.9% Saline, blunt trauma (n = 23)


OutcomesPrimary outcomes were the volumes of first fluid needed in the first 24 hours, and normal GI function by day 5


NotesMortality was not reported on the main publication but it was available from an author's reply .


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskPlastic bags with concealed label were randomly selected and placed sequentially in a warming cabinet

Jelenko 1978

MethodsRCT, method of allocation concealment unclear
Blinding not mentioned
No loss to follow-up


Participants19 people with burns covering more than 20% of body surface


Interventions
  1. 12.5% Albumin in hypertonic saline (240 mEq/L sodium, 120 mEq/L chloride, 120 mEq/L lactate) (n = 7)
  2. Hypertonic saline (240 mEq/L sodium, 120 mEq/L chloride, 120 mEq/L lactate) (n = 5)
  3. Ringer's lactate (n = 7)


Allocated fluid was used, guided by haemodynamic variables, to the end of resuscitation


OutcomesDeaths reported
Haemodynamic variables


NotesFollow-up to end of resuscitation


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Karanko 1987

MethodsRCT, description of allocation procedure unclear
Blinding not mentioned
No loss to follow-up


Participants32 adult men scheduled for coronary artery bypass surgery
Exclusion criteria: LVEF < 40%, abnormal lung function


Interventions
  1. 6% Dextran 70 (n = 14)
  2. Ringer's lactate (n = 18)


Allocated fluid was used to the end of resuscitation


OutcomesDeaths reported
Haemodynamic variables
Pulmonary oedema


NotesFollow-up 2 weeks


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Lang 2001

MethodsRCT, using a closed-envelope system


Participants42 patients scheduled for elective major abdominal surgery


Interventions
  1. Ringer's lactate (n = 21)
  2. 6% HES, molecular weight 139 kDa, degree of substitution 0.4 (n = 21)


OutcomesDeaths
Haemodynamics and laboratory data
Tissue oxygenation
Volume input and output


NotesFollow-up period unclear


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Lang 2003

MethodsRCT, allocation concealment not clearly reported ("closed envelope system")
Blinding method not reported ("...treatment in the ICU was performed by physicians who were blinded to the study")


Participants36 patients undergoing elective major abdominal surgery
Exclusion criteria: myocardial failure, renal insufficiency, severe pulmonary disease, liver dysfunction, diabetes mellitus, steroid therapy, pre-existing viral or bacterial infection and known allergic reactions to starch preparations


Interventions
  1. 6% HES (n = 18)
  2. Ringer's lactate (n = 18)


Additional crystalloid solutions were supplied to equalise insensible fluid loss or as a solvent for drugs in group 1


OutcomesPro- and anti-inflammatory cytokines
All patients survived


NotesLength of follow-up not reported but all outcomes were in-hospital measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Lee 2011

MethodsRCT method of allocation concealment not reported

open label trial but the endpoints were assessed blindly


Participants106 patients undergoing off-pump coronary artery bypass surgery and receiving with dual antiplatelet therapy (DAPT) within 5 days of surgery

Exclusion criteria: emergency surgery, myocardial infarction (MI), history of previous cardiac surgery, history of bleeding diathesis or hepatic dysfunction, left ventricular ejection fraction <40%,hemoglobin <12 g/dl, platelet count <100,000 mm3, abnormal
prothrombin time (international normalization ratio [INR]) and activated partial thromboplastin time (aPTT), creatinine >1.4 mg/dl, and use of glycoprotein IIb/IIIa inhibitors


Interventions1. HES 130/0.4 (n=53)

2. Crystalloids (n=53)


OutcomesBlood loss, infused fluid volume, urine output, and transfusion requirements, stroke, renal dysfunction, cardiac surgery reoperation, prolonged ventilation, wound infection


NotesDeath not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskNot reported

Ley 1990

MethodsRCT, method of allocation concealment unclear
Assessment of chest x-ray blinded
No loss to follow-up


Participants21 people undergoing coronary artery bypass grafting or valve surgery


Interventions
  1. 6% Hetastarch up to 1.5 L then 5% plasma protein fraction (n = 11)
  2. 0.9% Saline (n = 10)


Allocated fluid was used for postoperative fluid resuscitation


OutcomesDeaths were not reported
Pulmonary and peripheral oedema
Haemodynamic variables


NotesFollow-up to discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Lowe 1977

MethodsRCT, allocation by sealed envelopes
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants with serious trauma


Interventions
  1. 25% Albumin in Ringer's lactate (n = 77)
  2. Ringer's lactate (n = 94)


Allocated fluid was used throughout the pre- and intraoperative period


OutcomesDeaths reported


NotesFollow-up to 5 days postoperatively. Data on the 30 participants with chest injuries who were left out of the Lowe 1977 report, but included in Moss 1981, have been included in the meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Lu 2012

MethodsRandomised controlled study


Participants42 patients with septic shock


Interventions
  1. Ringer's lactate (n = 20)
  2. HES 130/0.4 (n = 22)


OutcomesMortality, fluid replacement, use of vasoactive drugs and inflammatory markers


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Lucas 1978

MethodsRCT, randomisation was based on the last digit of each patient's case number


Participants52 seriously injured patients


Interventions
  1. Standard resuscitation regimen ('balanced electrolyte', blood, fresh frozen plasma) plus salt-poor albumin, maximum 150 g during surgery and 150 g/day for the next 5 days (n = 27)
  2. Standard resuscitation regimen as above (n = 25)


OutcomesDeaths reported in some patients


NotesIn the final report of 94 randomised patients deaths were not reported. However, in this preliminary report of 52 injured patients deaths were reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Maitland 2005

MethodsRCT, open label, random allocation was assigned by the use of sealed cards
No loss to follow-up


Participants159 children with severe malaria and metabolic acidosis
Exclusion criteria: pulmonary oedema, oedematous malnutrition or papilloedema


InterventionsSevere acidosis

  1. 4.5% Albumin (n = 23)
  2. 0.9% Saline (n = 26)


Moderate acidosis

  1. 4.5% Albumin (n = 33)
  2. 0.9% Saline (n = 35)
  3. Control (n = 33)


OutcomesReduction in base deficit
Neurological sequelae
Death reported


NotesLength of follow-up not reported but all outcomes were in-hospital measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Maitland 2011

Methods2 stratum multicentre open, RCT


ParticipantsChildren aged between 60 days and 12 years, with severe febrile illness, randomly assigned within 2 strata (stratum A was children with severe febrile illness and impaired perfusion but without severe hypotension; stratum B was children with severe hypotension)


InterventionsChildren were randomly allocated to rapid volume replacement over the course of 1 hour with either:

  1. 20 mL 5% Human albumin solution per kg body weight (n = 1063)
  2. 20 mL 0.9% Saline solution per kg body weight (n = 1063)


OutcomesMortality at 4 weeks after randomisation


NotesChildren (n = 1044) assigned to no treatment were not included in the analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskTrial numbers kept inside opaque, sealed envelopes. Opened in numerical order by clinician

Mattox 1991

MethodsRandomised, allocation by alternation
Double-blind
2 patients excluded from the analysis as code of fluid lost


ParticipantsParticipants were pre-hospital trauma victims attended to by emergency personnel within 1 hour of injury, with SBP ≤ 90 mmHg, ≥ 16 years. 72% of participants had sustained penetrating trauma


Interventions
  1. 250 mL Dextran 70 in 7.5% saline (n = 211)
  2. 250 mL Ringer's lactate, saline or plasmalyte (n = 211)


Allocated fluid was for initial pre-hospital resuscitation only


OutcomesDeaths reported


NotesFollow-up to hospital discharge or transfer


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Mazher 1998

MethodsPatients "randomized"
Blinding of carers by use of pharmacy-prepared solutions
No loss to follow-up


ParticipantsPatients undergoing elective coronary artery surgery
Exclusion criteria: age > 75 years, ejection fraction < 35%, creatinine > 135 μmol/L, ACE inhibitors


Interventions
  1. 5 mL/kg Polygeline (n = 10)
  2. 5 mL/kg 7.2% Saline (n = 10)


Allocated fluid given postoperatively over 1 hour. All patients subsequently receive polygeline and RBCs


OutcomesHaemodynamic variables
Death


NotesFollow-up to discharge from ICU


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

McIntyre 2008

MethodsA feasibility RCT


ParticipantsPatients with early septic shock defined with at least 2 systemic inflammatory response syndrome criteria, infectious source and persistent hypotension after > 1 L of crystalloid fluid


Interventions
  1. Normal saline (n = 19)
  2. Pentastarch (n = 21)


OutcomesPrimary outcomes were feasibility measures for the pilot RCT. ICU and 28-day mortality were also reported


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskOnly the designated research pharmacist at each institution was aware of the treatment allocation for individual patients. Study fluids were prepared and blinded ahead of time by the site research pharmacist

McNulty 1993

MethodsRCT, method of allocation concealment not described
Blinding not mentioned
No loss to follow-up


ParticipantsPatients following elective cardiopulmonary bypass


Interventions
  1. 5% Albumin and cell-saved blood (n = 14)
  2. Plasmalyte and cell-saved blood (n = 14)


Allocated fluid used as part of fluid volume replacement


OutcomesDeaths not reported
Study was designed to look at the effect of protein infusion on the accuracy of a haematocrit measuring device


NotesLength of follow-up unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Metildi 1984

MethodsRCT
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were admissions to an ICU and a trauma unit with ARDS and established pulmonary failure. Included both trauma and non-trauma patients


Interventions
  1. 5% Salt-poor albumin (n = 20)
  2. Ringer's lactate (n = 26)


Allocated fluid was used throughout resuscitation, and if an operation was required the allocated fluid was used for volume replacement before and during the operation


OutcomesDeaths reported
Haemodynamic variables


NotesFollow-up to discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Modig 1983

MethodsRCT, allocation by admission date
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were trauma admissions to an emergency department with SBP < 70 mmHg. Age range 20 to 58 years


Interventions
  1. Dextran 70 in Ringer's lactate (n = 12)
  2. Ringer's lactate (n = 11)


Allocated fluids were given as the initial resuscitation fluid on admission to the emergency department, and continued as needed until after the 6th day when major reconstructive surgery was undertaken


OutcomesDeaths reported
Development of ARDS


NotesFollow-up to definitive reconstructive surgery


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Moretti 2003

MethodsRCT, allocation concealment method not clearly reported ("Patients randomized...by using a closed-envelope technique")
Blinding method not clearly reported ("Researchers were unaware of the patient's randomization")
No loss to follow-up


Participants90 adult patients undergoing major elective general, gynaecological, orthopaedic or urological surgery with an anticipated blood loss > 500 mL
Exclusion criteria: age < 16 years, coagulopathy, renal or hepatic dysfunction and congestive heart failure


Interventions
  1. Hetastarch-normal saline (n = 30)
  2. Hetastarch-balanced salt (n = 30)
  3. Ringer's lactate (n = 30)


OutcomesPostoperative nausea and vomiting
Death not reported


NotesFollow-up to discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Myburgh 2012

MethodsRCT, randomly assigned over an encrypted Web-based randomization system

Less than 5% loss to follow-up


Participants7000 patients 18 years or older addmited in ICU whom the treating clinician judged to require fluid resuscitation

Exclusion criteria: Patients who had received more than 1000 ml of HES before screening, those with impending or current dialysis-dependent renal failure, and those with evidence of intracranial hemorrhage

Setting: New Zealand and Australia


Interventions1. 6% HES 130/0.4 in 0.9% sodium chloride (n=3,500)

2. 0.9% sodium chloride (n=3,500)


OutcomesAll-cause mortality at 90 days, kidney injury, organ failure, duration of mechanical ventilation and renal replacement therapy, cause-specific mortality


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskweb-based allocation and identical packaging

Nagy 1993

MethodsRCT, contact with author showed it was an open-label study
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were adult admissions to a trauma unit, with measurable SBP < 90 mmHg


Interventions
  1. Pentastarch in 0.9% saline (n = 21)
  2. Ringer's lactate (n = 20)


Allocated fluid was used throughout resuscitation with the exception that colloid patients received a maximum 4 L of pentastarch, after which Ringer's lactate was given


OutcomesDeaths were not reported
Haemodynamic variables


NotesFollow-up to discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskInadequate

Ngo 2001

MethodsRCT, opaque envelopes containing only treatment pack number


Participants230 children with dengue shock syndrome


Interventions
  1. Dextran 70 (n = 55)
  2. 3% Gelatin (n = 56)
  3. Ringer's lactate (n = 55)
  4. 'Normal' saline (n = 56)


OutcomesInitial pulse recovery time
Occurrence of timing and subsequent episodes of shock
Decrease in haematocrit
Volume of fluid administered until recovery
Complications
No deaths in any group


NotesFollow-up period unclear


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Nielsen 1985

MethodsRCT, method of allocation concealment not described
Blinding not mentioned
No loss to follow-up


Participants26 patients admitted for reconstructive surgery of the abdominal aorta


Interventions
  1. Whole blood, crystalloid plus 80 g albumin on the day of the operation, and 20 g/day for the next 3 days. Albumin given as 100 mL 20% human albumin solution (n = 13)
  2. Whole blood and crystalloid, type not specified (n = 13)


OutcomesDeaths not reported
Author when contacted confirmed that there were no deaths in either group


NotesLength of follow-up 4 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Perner 2012

MethodsRCT

Computer-generated allocation sequence and centralized, blinded allocation


Participants804 patients 18 years of age or older who needed fluid resuscitation in the ICU, and who fulfilled the criteria for severe sepsis within the previous 24 hours

Exclusion criteria: renal replacement therapy, kidney or liver transpant, burn injury (>10%), intracranial bleeding, K > 6mmol per litre, received >1000 ml colloid, included in another ICU trial, withdrew from active therapy

Setting: Denmark, Norway, Finland and Iceland


Interventions1. 6% HES 130/0.42 (n=400)

2. Ringer acetate (n=400)


OutcomesDeath at 28 days 90 days and at time of latest follow-up , dependence on dialysis 90 days after randomization, severe bleeding, severe allergic reaction, SOFA score, acidosis, days alive without renal replacement, days alive without mechanical ventilation, days alive out of the hospital in the 90 days after randomisation


NotesFour patients were excluded after randomisation and two patients had incomplete outcome data in the 6% HES 130/0.42 group


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskcentralised blinded allocation

Pockaj 1994

MethodsRCT, allocation concealment unclear
Blinding not mentioned
Loss to follow-up: 18/54 in colloid group, 13/53 in saline group


ParticipantsParticipants required fluid resuscitation as a result of vascular leak syndrome associated with interleukin-2 therapy for metastatic cancer


Interventions
  1. 250 mL Bolus of 5% albumin in saline (n = 36 reported)
  2. 250 mL Bolus of 0.9% normal saline (n = 40 reported)


Boluses guided by haemodynamic variables. Both groups also received 0.45% saline with 10 mmol/L KCl


OutcomesDeaths
Toxic effects of chemotherapy
Haemodynamic variables


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Prien 1990

MethodsRCT
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were undergoing modified Whipple's operation


Interventions
  1. 10% HES in 0.9% saline plus plasma protein fraction if requirements > 20 mL/kg (n = 6)
  2. 20% human albumin solution (n = 6)
  3. Ringer's lactate (n = 6)


Allocated fluid was administered intraoperatively only


OutcomesDeaths
Intestinal oedema formation


NotesFollow-up period was unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Rackow 1983

MethodsRCT, allocation concealment unclear
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were aged 54 to 97 years, and had any 1 of the following pre-determined indicators of shock: SBP ≤ 90 mmHg, cardiac index < 2.2 L/minute/m2, serum arterial lactate > 18 mg/dL and WP < 15 mmHg


Interventions
  1. 6% HES (n = 9)
  2. 5% Albumin (n = 9)
  3. 0.9% Saline (n = 8)


Allocated fluid was given as needed until the end of resuscitation


OutcomesDeaths reported
Fluid balance


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Rocha e Silva 1994

MethodsRCT


ParticipantsParticipants were admissions to the emergency department, with SBP ≤ 90 mmHg and ≥ 16 years of age


Interventions
  1. 6% Dextran 70 in 7.5% saline
  2. Ringer's lactate


Allocated fluid was used for the first IV infusion only


OutcomesDeath was the main outcome measure, but the data are unpublished


NotesFollow-up to 30 days. By April 1994, 125 patients had been entered into the study


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

SAFE 2004

MethodsRCT. Randomisation by minimisation algorithm accessed through secure website


ParticipantsPatients aged ≥ 18 years admitted to closed multidisciplinary ICUs in 16 tertiary hospitals in Australia over 19-month period


Interventions
  1. 4% Albumin (Albumex, CSL) (n = 3499)
  2. Normal saline (n = 3501)


OutcomesDeath
Patients with new single- or multiple-organ failure
Mean number of days: in ICU, in hospital, on mechanical ventilation, on renal replacement therapy


NotesFollow-up to 28 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Shah 1977

MethodsRCT, allocation by sealed envelope
Blinding not mentioned
No loss to follow-up


ParticipantsPatients with severe, multiple trauma and SBP < 90 mmHg. All patients were adults and both sexes were included


Interventions
  1. 5% Salt-poor albumin in Ringer's lactate (n = 9)
  2. Ringer's lactate (n = 11)


Volume infused guided by physiological parameters


OutcomesDeath reported
Haemodynamic variables


NotesLength of follow-up not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Shires 1983

MethodsPatients 'assigned randomly'
Blinding not mentioned
No loss to follow-up


ParticipantsPeople undergoing aortic reconstruction surgery
No exclusion criteria mentioned


Interventions
  1. Plasmanate (n = 9)
  2. Ringer's lactate (n = 9)


Allocated fluid used guided by haemodynamic variables until the first postoperative morning. All patients then received 0.45% saline


OutcomesPulmonary oedema
Haemodynamic variables
Death


NotesFollow-up to 2 days postoperative


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Sirieix 1999

MethodsPatients "randomly assigned"

Blinding not described
2 patients excluded after randomisation due to arrhythmias on giving the fluid (both in hypertonic saline group)


ParticipantsPatients undergoing mitral valve repair
Exclusion criteria: LVEF < 0.4, systolic PAP > 50 mmHg, coagulation disorders, creatinine > 150 mmoL/L, electrolyte imbalance, diabetes, previous atrial fibrillation lasting > 1 year


Interventions
  1. 250 mL 7.2% Hypertonic saline, 6% HES (n = 8)
  2. 250 mL 7.2% Hypertonic saline (n = 10)
  3. 250 mL 6% HES (n = 8)


Fluid given over 15 minutes, 1 hour after admission to postoperative ICU


OutcomesHaemodynamic variables
Deaths reported
Side effects (severe hypotension: 1 patient in group 1 and 2 patients in group 2; arrhythmias: 1 patient in group 1, 3 patients in group 2 and 1 patient in group 3)


NotesFollow-up to discharge from hospital (all within 10 days)


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Skillman 1975

MethodsRCT, allocation concealment unclear
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were undergoing elective abdominal reconstructive surgery


Interventions
  1. 25% Salt-poor albumin 1 g/kg and 5% albumin 1 L (n = 7)
  2. Ringer's lactate


Allocated fluid was given intraoperatively. All patients received crystalloids only for pre-loading before surgery


OutcomesDeaths were not reported


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Tollofsrud 1995

MethodsRCT, allocation by sealed envelopes
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were adults in need of volume replacement during and after coronary artery bypass surgery


Interventions
  1. Haemaccel (n = 10)
  2. Dextran 70 (n = 10)
  3. Albumin 40 (n = 10)
  4. Ringer's lactate (n = 10)


Allocated fluid was used throughout resuscitation


OutcomesDeaths reported
Fluid balance


NotesFollow-up to 48 hours


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Tollofsrud 1998

MethodsRCT, allocation by sealed envelope

Described as double blind

No loss to follow-up mentioned


ParticipantsPatients with 3 vessel coronary artery disease undergoing elective coronary artery surgery

Exclusion criteria: LVEF < 0.4, ventricular aneurysm, significant arrhythmia, diabetes, renal failure, lung disease


Interventions
  1. 4 mL/kg of 75 mg/mL hypertonic saline in dextran 70 60 mg/mL over 30 minutes (n = 10)
  2. Same volume and rate of isotonic saline (n = 10)


Fluid given just after surgery while still in operating theatre. Ringer's lactate for additional fluid


OutcomesFluid balance
Haemodynamic variables
Deaths not reported


NotesFollow-up to 48 hours


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Upadhyay 2004

MethodsOpen-label randomised trial, allocation by sealed envelope
No loss to follow-up mentioned


Participants60 patients with septic shock aged 1 month to 12 years
Exclusion criteria: age < 1 month, multiorgan failure and immunodeficiency states


Interventions
  1. Normal saline (n = 31)
  2. Polymer from degraded gelatin in saline (n = 29)


OutcomesHaemodynamic data
Death reported


NotesLength of follow-up not reported but all outcomes were in-hospital measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Vassar 1990

MethodsRCT, allocation concealment unclear
Double-blind study (solutions prepared in identical containers)
No loss to follow-up


ParticipantsParticipants were emergency department admissions with trauma and SBP < 80 mmHg and ≥ 18 years of age
Exclusion criteria: pregnant women and people with pre-existing cardiac, hepatic or renal disease


Interventions
  1. 6% Dextran 70 in 7.5% saline (n = 23)
  2. Ringer's lactate (n = 24)


Allocated fluids were given as the initial resuscitation in the emergency department. Additional isotonic crystalloids (Ringer's lactate) were given as needed


OutcomesDeaths reported
Haemodynamic variables


NotesFollow-up to hospital discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Vassar 1991

MethodsRCT, allocation by randomised sequence of coded containers
Double-blind study
No loss to follow-up


ParticipantsParticipants were pre-hospital trauma cases undergoing helicopter transport to an emergency centre, with SBP ≤ 100 mmHg and ≥ 18 years
Exclusion criteria: pre-existing cardiac renal, hepatic or neurological disease; peripheral oedema


Interventions
  1. 4.2% Dextran 70 in 7.5% saline or 6% dextran 70 in 7.5% saline (n = 83)
  2. Ringer's lactate (n = 83)


Fluids were given as the initial resuscitation fluid in the pre-hospital setting. Supplemental isotonic fluids were given at the discretion of the flight nurses


OutcomesDeaths reported
Haemodynamic variables


NotesFollow-up to discharge. Allocation was to 4.2% dextran 70, to 6% dextran 70, or to crystalloid; for the calculation of the summary effect measure, the 2 dextran groups were combined


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Vassar 1993a

MethodsRCT, allocation concealed by random sequence of identical containers
Double-blind study
36 people excluded post randomisation as deemed not to have met eligibility criteria
No loss to follow-up


ParticipantsParticipants, who were undergoing ambulance transport to an emergency centre, SBP ≤ 90 mmHg, ≥ 18 years
Exclusion criteria: asystolic; undergoing CPR; lack sinus complex on ECG; > 2 hours after trauma; pregnant; pre-existing seizures; bleeding disorder; hepatic, cardiac or renal disease


Interventions
  1. 6% Dextran 70 in 7.5% saline (n = 89)
  2. 7.5% Saline (n = 85)
  3. 0.9% Saline (n = 84)


Participants received 250 mL of the allocated fluid in the pre-hospital setting. Additional isotonic crystalloids were given as needed


OutcomesDeaths reported
Haemodynamic variables
Trauma scores


NotesFollow-up was to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Vassar 1993b

MethodsRCT, allocation concealed by sequential use of coded identical containers
Double-blind study
39/233 patients excluded as deemed not to meet eligibility criteria, unclear from which groups


ParticipantsParticipants were pre-hospital trauma cases undergoing helicopter transport to an emergency centre, SBP ≤ 100 mmHg, ≥ 18 years
Exclusion criteria: asystolic; undergoing CPR; lack sinus complex on ECG; > 2 hours after trauma; pregnant; pre-existing seizures; bleeding disorder; hepatic, cardiac or renal disease


Interventions
  1. 12% Dextran 70 in 7.5% saline (n = 49)
  2. 6% Dextran 70 in 7.5% saline (n = 50)
  3. 7.5% Saline (n = 50)
  4. Ringer's lactate (n = 45)


Participants received 250 mL of the allocated fluid in the pre-hospital setting. Additional isotonic crystalloids were given as needed


OutcomesDeaths reported
Haemodynamic variables
Trauma scores and neurological outcome scores


NotesFollow-up to hospital discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Verheij 2006

MethodsRCT, allocation concealment by "the sealed envelope method"
Blinding method not reported
No loss to follow-up


Participants67 patients with presumed hypovolaemia after cardiac and major vascular surgery
Exclusion criteria: age > 79 years and known anaphylactoid reaction to colloids


Interventions
  1. Saline (n = 16)
  2. Gelatin (n = 16)
  3. HES (n = 16)
  4. Albumin (n = 16)


OutcomesHaemodynamic data
Death not reported


NotesLength of follow-up not reported but all outcomes were in-hospital measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Virgilio 1979

MethodsAllocation "by random number"
Blinding not mentioned
No loss to follow-up


ParticipantsParticipants were undergoing abdominal aortic surgery


Interventions
  1. 5% Albumin (n = 15)
  2. Ringer's lactate (n = 14)


Allocated fluid was used during operation for maintenance of pre-defined physiological parameters, and the resuscitation was continued with the allocated fluid until the day following the operation. This was followed by 5% dextrose in half-normal saline, with potassium chloride as needed


OutcomesDeaths reported


NotesFollow-up 2.5 weeks


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Wahba 1996

MethodsPatients "randomly allocated"
Blinding not mentioned
2 patients excluded as they required reoperation for bleeding


Participants22 adults in need of volume replacement following coronary artery bypass surgery
Exclusion criteria: abnormal left ventricular function, platelet active medication or heparin


Interventions
  1. Haemaccel (n = 10)
  2. Ringer's lactate (n = 10)


Allocated fluid was used from the time of admission to ICU following operation, to the end of resuscitation


OutcomesDeaths reported
Pulmonary oedema


NotesFollow-up to discharge


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Wills 2005

MethodsRCT, allocation concealed by specially prepared cardboard containers
Method of blinding not mentioned
No loss to follow-up


Participants512 children with dengue shock syndrome aged 2 to 15 years


InterventionsChildren with immoderately severe shock were randomised to the 3 interventions

  1. Ringer's lactate (n = 128)
  2. 6% Dextran 70 (n = 126)
  3. 6% HES 200/0.5 (n = 129)


Children with severe shock were randomised only to either of the 2 colloids interventions:

  1. 6% Dextran 70 (n = 67)
  2. 6% HES 200/0.5 (n = 62)


OutcomesRequirement for supplemental intervention with rescue colloid
Time taken to achieve initial cardiovascular stability
Time taken to achieve sustained cardiovascular stability
Volume required
Change in haematocrit
Days in hospital
1 death reported but not specified in which group


NotesLength of follow-up not clear


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskAdequate

Woittiez 1997

MethodsRCT, allocation concealment by sealed opaque envelopes
No information on blinding or loss to follow-up


Participants60 patients who had developed hypoalbuminaemia (< 20 g/L) after major surgery
2 patients died after randomisation and before treatment started. They were excluded from the analysis


Interventions
  1. Saline (500 mL/24 hours) (n = 16)
  2. 20% Albumin (300 mL/24 hours) (n = 15)
  3. 10% HES (500 mL/24 hours) for 3 days (n = 27)


Aim was to restore COP


OutcomesChanges in fluid balance, serum albumin, COP and clinical signs of oedema were followed daily
Death rates supplied by the author


NotesLength of follow-up unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Wu 2001

MethodsRCT. No details given of randomisation method


Participants41 adolescent or adult patients in emergency department suffering from shock


Interventions
  1. 4% Modified fluid gelatin: succinated gelatin 40 g/L, sodium chloride 7 g/L, sodium hydroxide 1.36 g/L (n = 18)
  2. Ringer's lactate (n = 16)


OutcomesDeath
Haemodynamic variables


NotesNot intention-to-treat: 5 patients who received blood transfusion and 2 who had surgery within the first hour of resuscitation were dropped from the analysis
Length of follow-up not clear


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Younes 1992

MethodsRandomised "in a double blind fashion"
Blinding by use of similar bottles
No loss to follow-up


ParticipantsParticipants were emergency department admissions, SBP < 80 mmHg, ≥ 19 years
Exclusion criteria: pregnant, pre-existing cardiac or metabolic disease


Interventions
  1. 6% Dextran 70 in 7.5% saline (n = 35)
  2. 7.5% Saline (n = 35)
  3. 0.9% Saline (n = 35)


Allocated fluid was for initial bolus of 250 mL, followed by isotonic crystalloids as needed


OutcomesDeaths reported
Fluid balance


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Younes 1994

MethodsTrial conducted in a "double blind randomised fashion"
Blinding by use of coded, identical containers


ParticipantsParticipants were trauma admissions to the emergency department requiring treatment for haemorrhagic hypovolaemia; all were over 15 years old
Exclusion criteria: pregnant, cardiac or renal failure, cardiac arrest on arrival


Interventions
  1. 6% Dextran 70 in 7.5% saline (n = 101)
  2. 0.9% Saline (n = 111)


Allocated fluid was for the first IV infusion only


OutcomesDeaths reported
Complications


NotesFollow-up period was 30 days


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Younes 1998

MethodsRCT, allocation by sealed envelope

Blinding not mentioned

No apparent loss to follow-up


ParticipantsTrauma patients SBP < 90 mmHg admitted to the emergency department, with no previous treatment


Interventions
  1. 10% Pentastarch (n = 12)
  2. 0.9% Saline (n = 11)


Fluid given in 250 mL boluses until systolic blood pressure > 100 mmHg


OutcomesDeaths reported
No complications reported in either group


NotesFollow-up to 24 hours


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Zetterstrom 1981a

MethodsThe patients were randomly divided into 2 groups
Allocation concealment was by sealed opaque envelopes (information supplied by study author)
Blinding not mentioned
No loss to follow-up


ParticipantsAdults undergoing elective major abdominal surgery


Interventions
  1. Standard volume replacement regimen (1 L dextran 70 then up to 4 units of RBC with electrolyte, then whole blood or RBC with plasma; postoperative patients were given crystalloids and whole blood) plus 20% human albumin solution 100 mL at end of operation, 200 mL to 300 mL on same day, then 200 mL on first postoperative day, then 100 mL for next 3 days (n = 15)
  2. Standard volume replacement regimen (as above) (n = 15)


OutcomesDeaths reported
Haemodynamic variables


NotesLength of follow-up unspecified


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Zetterstrom 1981b

MethodsPatients were randomly divided into 2 groups
Allocation concealment was by sealed opaque envelopes (information supplied by study author)
Blinding not mentioned
No loss to follow-up


Participants18 patients who had undergone elective abdominal aortic surgery
No exclusions mentioned


Interventions
  1. 5% Human albumin solution (n = 9)
  2. Ringer's lactate solution (n = 9)


Administration guided by pulmonary arterial occlusion pressure


OutcomesDeaths reported
Haemodynamic variables


NotesFollow-up to discharge from hospital


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

Zhu 2011

MethodsRCT


Participants135 participants with severe sepsis


Interventions
  1. 7.5% Hypertonic saline plus 6% HES 130/0.4 (n = 45)
  2. Ringer's lactate plus 6% HES 130/0.4 (n = 45)
  3. Ringer's lactate (n = 45)


OutcomesBiomarkers, fluid requirements, and MODS. Mortality was also reported


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskUnclear

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Artru 1989Intervention to control intracranial pressure not directed at fluid resuscitation

Bocanegra 1966Study contained 2 quasi-randomised comparisons of colloid with glucose and plasma/saline with saline. In both studies, the control solution was only given IV if the patient was in coma or shock. It was therefore not a reasonable comparison of colloid and crystalloid

Boldt 1996All groups received some colloid

Boldt 2007Comparison was not between colloids and crystalloids, rather 2 different colloid solutions

Bothner 1998Participants were having minor elective surgery, therefore not considered to be critically ill

Breheme 1993Intervention directed at haemodilution, not at volume replacement

Bueno R 2004The participants had elective surgery

Chin 2006Participants were undergoing elective surgery, therefore not considered to be critically ill

Golub 1994Albumin given solely as a nutritional supplement

Goslinga 1992Intervention directed at haemodilution, not volume replacement

Green 2008Article is a review

Greenhalgh 1995Intervention directed at the maintenance of serum albumin levels, not for volume replacement

Hauser 1980Cross-over trial

Ko 2007Comparison of crystalloids and colloids as pre-loading solutions

Krasheninnikov 2007Not an RCT

Lagonidis 1995Intervention was pre-loading for coronary artery bypass surgery

Lange 2011Article was a review

Lobo 2008Experiment conducted on rabbits

Marhofer 1999Trial of fluid for pre-loading before spinal anaesthesia

Mittermayr 2007Patients were undergoing elective surgery

Mittermayr 2008Outcome was the change in concentration of tissue-type plasminogen activator

Morrison 2011Study evaluated the effect of hypertonic saline in patients with blunt head injury

Niemi 2008Solutions were used for pump priming

Nilsson 1980Albumin given as a nutritional supplement

Oliviera 2002The participants had sepsis

Paton-Gay 2007The outcome was non-relevant to comparing crystalloids and colloids

Paul 2003The participants had elective surgery

Rehm 20012 colloids (albumin and hetastarch) compared

Steinberg 1989Cross-over trial

Tiryakioglu 2008Patients were undergoing elective surgery and not considered critically ill. Also, the solutions were used as priming solutions

Tseng 2008Crystalloid and colloid treatment was not randomised

Valetova 2007Patients were randomised depending upon their treatment not prior to treatment

van der Heijden 2009The report did not provide separate data for the 3 arms that received colloids (gelatin 4%, hydroxyethyl starch 6% and albumin 5%)

Vercueil 2006Article is a review

Wilkes 20011 group received saline plus hetastarch, the other received 'balanced' fluid plus hetastarch. Thus, each group received both a colloid and a crystalloid. This conflicts with the purpose our review, which compares patients who had 1 of these with patients who had the other

Woods 1993This quasi-randomised trial looked at albumin supplementation in postoperative patients, with the aim of maintaining the serum albumin. Since the main aim of giving albumin was not to replace volume, the study was excluded

 
Characteristics of ongoing studies [ordered by study ID]
RASP trial

Trial name or titleLactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

MethodsRCT

Participants360 patients with severe sepsis or septic shock

Interventions
  1. Ringer's lactate
  2. 4% Albumin

Outcomes28 days all-cause mortality

Starting dateMay 2012

Contact informationJuliano P Almeida, Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo

NotesNCT01337934

 
Comparison 1. Colloid versus crystalloid (add-on colloid)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Deaths56Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Albumin or plasma protein fraction
249920Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.93, 1.10]

    1.2 Hydroxyethyl starch
259147Risk Ratio (M-H, Fixed, 95% CI)1.10 [1.02, 1.19]

    1.3 Modified gelatin
11506Risk Ratio (M-H, Fixed, 95% CI)0.91 [0.49, 1.72]

    1.4 Dextran
9834Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.94, 1.65]

 
Comparison 2. Colloid and hypertonic crystalloid versus isotonic crystalloid

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Deaths11Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Albumin or plasma protein fraction
114Risk Ratio (M-H, Fixed, 95% CI)0.5 [0.06, 4.33]

    1.2 Hydroxyethyl starch
190Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.03, 2.15]

   1.3 Modified gelatin
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.4 Dextran
91879Risk Ratio (M-H, Fixed, 95% CI)0.91 [0.79, 1.06]

 
Comparison 3. Colloid versus hypertonic crystalloid

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Deaths3Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Albumin or plasma protein fraction
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Hydroxyethyl starch
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Modified gelatin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

   1.4 Dextran
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]