Get access

Hydroxyethyl starch (HES) versus other fluid therapies: effects on kidney function

  • Review
  • Intervention

Authors


Abstract

Background

Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation, yet controversy exists about their impact on kidney function.

Objectives

To examine the effects of HES on kidney function compared to other fluid resuscitation therapies in different patient populations.

Search methods

We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library), MEDLINE, EMBASE, MetaRegister and reference lists of articles.

Selection criteria

Randomised controlled trials (RCTs) and quasi-RCTs in which HES was compared to an alternate fluid therapy for the prevention or treatment of effective intravascular volume depletion. Primary outcomes were renal replacement therapy (RRT), author-defined kidney failure and acute kidney injury (AKI) as defined by the RIFLE criteria. Secondary outcomes included serum creatinine and creatinine clearance.  

Data collection and analysis

Screening, selection, data extraction and quality assessments for each retrieved article were carried out by two authors using standardised forms. Authors were contacted when published data were incomplete. Preplanned sensitivity and subgroup analyses were performed after data were analysed with a random effects model.

Main results

The review included 34 studies (2607 patients). Overall, the RR of author-defined kidney failure was 1.50 (95% CI 1.20 to 1.87; n = 1199) and 1.38 for requiring RRT (95% CI 0.89 to 2.16; n = 1236) in HES treated individuals compared with other fluid therapies. Subgroup analyses suggested increased risk in septic patients compared to non-septic (surgical/trauma) patients. Non-septic patient studies were smaller and had lower event rates, so subgroup differences may have been due to lack of statistical power in these studies. Only limited data was obtained for analysis of kidney outcomes by the RIFLE criteria. Overall, methodological quality of studies was good but subjective outcomes were potentially biased because most studies were unblinded.

Authors' conclusions

Potential for increased risk of AKI should be considered when weighing the risks and benefits of HES for volume resuscitation, particularly in septic patients. Large studies with adequate follow-up are required to evaluate the renal safety of HES products in non-septic patient populations. RIFLE criteria should be applied to evaluate kidney function in future studies of HES and, where data is available, to re-analyse those studies already published. There is inadequate clinical data to address the claim that safety differences exist between different HES products.  

摘要

Hydroxyethyl starch (HES)和其它輸液治療的比較:對於腎功能的影響

研究背景

Hydroxyethyl starches (HES)是一種合成的膠體,通常用於液體復甦,但目前仍存有其對腎功能影響的爭議。

研究目的

比較HES和其它液體復甦治療,對於不同病患族群腎功能的影響。

检索方法

我們搜尋了the Cochrane Renal Group's specialised register、the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library)、MEDLINE、EMBASE、MetaRegister及文章中的參考資料。

纳入标准

比較HES和其它輸液治療,用於預防或治療有效血管內容積不足的隨機(RCTs)和半隨機試驗。主要預後為腎臟替代治療(RRT)、作者定義的腎衰竭及RIFLE criteria定義的急性腎損傷(AKI)。次要預後包括血清肌酐酸及肌酐酸清除率。

数据收集与分析

由2位作者利用標準格式篩選和擷取數據,並且評估收錄研究的品質。當發表的數據不完整時,我們會和作者連絡。計畫前的敏感度和子群組分析以隨機效應模式進行分析。

主要结果

這篇評論收錄了34個研究(2607位病患)。總體而言,使用HES的組別比起其它輸液治療,作者定義的腎衰竭的RR是1.50(95% CI 1.20 to 1.87; n = 1199),腎臟替代療法需求的RR是1.38(95% CI 0.89 to 2.16; n = 1236)。子群組分析顯示敗血症病患比非敗血症(surgical/trauma)病患的風險高。非敗血症病患的研究規模較小,且事件發生率較低,因此子群組間的差異可能是因為這些研究缺乏統計檢定力所造成。只有取得有限的數據能利用RIFLE criteria做腎臟預後的分析。整體而言,這些研究的方法品質都很良好,但主觀預後有潛在的誤差,因為大部分的試驗都屬於非盲性試驗。

作者结论

當評估以HES作為容積復甦治療的風險和利益時,應該將增加潛在急性腎損傷風險列入考量,特別是對於敗血症病患。我們需要大型且有適當後續追蹤的研究,以評估HES對非敗血症病患的腎的安全性。未來的HES研究也應該要套用RIFLE criteria去評估腎功能,且在能取得數據的情況下,對已發表的研究做重新分析。目前沒有合適的臨床數據能讓宣稱不同的HES製劑存在安全性上的差異。

Plain language summary

Hydroxyethyl starch (HES) versus other fluid therapies: effects on kidney function

Hydroxyethyl starches (HES) are synthetic fluid products that are commonly used in clinical practice, however controversy exists about their effect on kidney function. This review examined the effects of HES on kidney function compared to other fluid therapies in critically ill patients. Thirty-four randomised clinical trials comparing HES to another fluid therapy qualified for the review. In surgical and trauma patients there was no difference with respect to risk of kidney failure or need for dialysis between treatment groups, possibly due to the low number of outcomes in these studies. In contrast, studies including sepsis patients revealed that HES treated individuals had a 55% increased risk of developing kidney failure and a 59% increased risk of requiring dialysis. Serum creatinine and creatinine clearance were evaluated as outcomes, however results were too different between patients and studies to be evaluated. Small studies of surgical patients comparing different HES products did not reveal significant differences, however there were too few patients to properly evaluate this outcome. Products with lower molecular weight and degree of substitution are reported to have better safety profiles, however insufficient evidence exists in the literature to support this.

概要

Hydroxyethyl starch (HES)和其它輸液治療的比較:對於腎功能的影響

Hydroxyethyl starch (HES)和其它輸液治療的比較:對於腎功能的影響:Hydroxyethyl starches (HES)是一種常用於臨床的合成液體製劑,但目前仍存有它對腎功能影響的爭議。本評論比較HES和其它輸液治療,對於重症病患腎功能的影響。34個隨機臨床試驗比較HES和其它輸液治療,符合本評論的收錄標準。在手術及創傷病患的腎衰竭風險或洗腎需求上,兩種治療組別沒有差異,可能是因為這些研究的預後數目較少。相反的,包含敗血症病患的研究,顯示使用HES的病患,在腎衰竭的風險上增加了55%,洗腎的風險也增加59%。血清肌酐酸和肌酐酸清除率也被作為預後指標,然而在病患和研究間有很大的差異。小型、以手術病患為樣本,比較各種HES製劑的研究,顯示各種HES沒有顯著的差異,但參與的病患過少,以致於無法做適當的評估。分子量較小及取代物較少的製劑被回報有較好的安全性,然而文獻中沒有足夠的證據能支持這個論點。

翻译注解

Ancillary