Characteristics of included studies [ordered by study ID]
Sayre 1996
|
| Methods | Randomised and double blind placebo controlled trial. |
|
| | Participants | Moderate and severe head injury (CGS 11 and less), above 18 years of age. |
|
| | Interventions | Mannitol received 5ml/kg of 20% mannitol through large-bore intravenous catheter over five minutes; placebo group were given5ml/kg of 0.9% saline solution. |
|
| | Outcomes | Death was reported. Length of follow-up was two hours after hospital admission. |
|
| | Notes | Testing pre-hospital administration of mannitol. |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Yes | A - Adequate |
|
|
Schwartz 1984
|
| Methods | Randomised single blind trial. |
|
| | Participants | Severe head injury (GCS<8). Participants had to have already been resuscitated and had raised ICP for more than 15 minutes. |
|
| | Interventions | The mannitol group received 20% mannitol solution at an initial dose of 1g per kg. Additional increments were given to maintain the intracranial pressure at less than 20 torr, within a serum osmolarity of mannitol of 320mOs/L.
The pentobarbital group received pentobarbital as an IV bolus of up to 10mg/kg, followed by a continuous infusion at 0.5-3 mg/kg/hr, provided that CPP remained above 50 torr, Additional increments of pentobarbital were given to maintain the intracranial pressure at less than 20 torr. |
|
| | Outcomes | Death reported. Follow-up to three months. |
|
| | Notes | For subsequent episodes of raised ICP, cross-over between the groups was allowed. |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Unclear | B - Unclear |
|
|
Smith 1986
|
| Methods | Randomised controlled trial; not reported as double-blind. |
|
| | Participants | Severe head injury (GCS 8 or less). |
|
| | Interventions | Compared two regimens of guiding the administration of mannitol, one according to neurological signs and physiological measurements, and the other using ICP monitoring. The protocol for the first group used neurological signs, GCS, ventilatory values and arterial blood gas to guide administration. In the second group, a 250ml bolus of mannitol (20%) was given if ICP >25mmHg, and subsequent boluses were given incrementally. |
|
| | Outcomes | Deaths and neurological disability were reported. Follow-up was one year. |
|
| | Notes | |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Unclear | D - Not used |
|
|
Vialet 2003
|
| Methods | Randomised single blind trial. |
|
| | Participants | Severe head injury (GCS<8) who required intravenous infusions of an osmotic agent to treat episodes of intracranial hypertension resistant to standard therapy. |
|
| | Interventions | Compared two osmotic agents, mannitol and hypertonic saline solution. The mannitol group received 20% mannitol solution. The hypertonic saline group received 7.5% hypertonic saline. The infused volume was the same for both solutions: 2 ml/kg body weight in 20 minutes. |
|
| | Outcomes | Death and neurological disability reported. Follow-up to three months. |
|
| | Notes | |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Unclear | B - Unclear |
|
|
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Battison 2005 | Cross-over design. |
| | Cruz 2001 | Concerns about the integrity of the trial data. Manuscripts does not indictate where the patients were randomised and despite an investigation by the Cochrane Injuries Group this remains open to question. |
| | Cruz 2002 | Concerns about the integrity of the trial data. Manuscripts does not indictate where the patients were randomised and despite an investigation by the Cochrane Injuries Group this remains open to question. |
| | Cruz 2004 | Concerns about the integrity of the trial data. Manuscripts does not indictate where the patients were randomised and despite an investigation by the Cochrane Injuries Group this remains open to question. |
| | Fortune 1995 | Controlled follow up study; no means to reduce bias in the selection of the control group was used. |
| | Gaab 1989 | Randomised to a diuretic, not necessarily mannitol. |
| | Levin 1979 | Participants were not all head injured; had a cross-over design. |
| | Midgely 1993 | Cross-over design. |
| | Smedema 1993 | Not all head-injured patients. |
|
|
Comparison 1. ICP-directed mannitol ('treatment') compared to mannitol according to neurological signs ('control')
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death | 1 | 77 | Risk Ratio (M-H, Fixed, 95% CI) | 0.83 [0.47, 1.46] |
| | 2 Death or severe disability | 1 | 77 | Risk Ratio (M-H, Fixed, 95% CI) | 0.88 [0.55, 1.38] |
|
|
Comparison 2. Mannitol versus pentobarbital
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death | 1 | 59 | Risk Ratio (M-H, Fixed, 95% CI) | 0.85 [0.52, 1.38] |
|
|
Comparison 3. Mannitol versus hypertonic saline
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death | 1 | 20 | Risk Ratio (M-H, Fixed, 95% CI) | 1.25 [0.47, 3.33] |
|
|
Comparison 4. Mannitol versus placebo
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death | 1 | 41 | Risk Ratio (M-H, Fixed, 95% CI) | 1.75 [0.48, 6.38] |
|
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