Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study

Schortgen, Frédérique; Lachérade, Jean-Claude; Bruneel, Fabrice; Cattaneo, Isabelle; Hémery, François; Lemaire, François; Brochard, Laurent

doi:10.1016/s0140-6736(00)04211-2

Cited by 688 publications

(417 citation statements)

References 32 publications

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“…This was previously found for other HES formulations [8,9,12] and suspected for 6% tetrastarch. [54] The point estimates are concordant and the pooled CI is narrower than already reported in trials, [3,25] improving precision.…”

Section: Discussionsupporting

confidence: 82%

“…Reporting of a mortality outcome at 90-days, and/or 28-days, and/or another follow-up time point. 9. At least one death in each of the 6% tetrastarch and control exposure groups (to facilitate meta-analysis).…”

Section: Eligibility Criteriamentioning

confidence: 99%

“…6% tetrastarch products have an average molecular weight of 130 kDa (±20 kDa), and somewhat overlapping molar substitution [3] clinical use, the safety and efficacy of HES are controversial. [4][5][6][7] Large critical care randomised controlled trials (RCTs) in severe sepsis reporting harm from HES, [8,9] concern over publication bias supporting HES, [5,6] and retraction of studies, have raised safety and efficacy concerns. [4,[10][11][12] 6% tetrastarch products were studied in eleven retracted papers, [13] however, severe sepsis patients were not the main study population in these.…”

Section: Introductionmentioning

confidence: 99%

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Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

2013

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PurposeTo assess the impact of 6% tetrastarch (hydroxyethyl starch (HES) 130/0.4 and 130/0.42) in severe sepsis patients. The primary outcome measure was 90-day mortality. MethodsA structured literature search to identify prospective randomized controlled trials (RCT) in adult patients with severe sepsis receiving 6% tetrastarch (potato or waxy maize origin), as part of fluid resuscitation in comparison to other non-HES fluids after randomisation, in the critical care setting was undertaken. A systematic review and meta-analysis was performed. ResultsSix RCTs were included (n = 3033): three from 2012 (n = 2913) had a low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30 to 43). Ninety-day mortality was associated with tetrastarch exposure (relative risk (RR) 1.13; 95% confidence interval (CI) 1.02 to 1.25; p = 0.02) compared to crystalloid. The number needed to harm (NNH) was 28.8 (95% CI 14.6 to 942.5). Publication bias and statistical heterogeneity (I 2 = 0%) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, comparison with colloid as control, and for waxy maize derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95% CI 1.02 to 1.25; p = 0.02). ConclusionsIn our analysis, 6% tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm, and as alternatives exist, in our view should be avoided.

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Section: Discussionsupporting

confidence: 82%

Section: Eligibility Criteriamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

2013

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“…11,12 Nonetheless, accrued data from these randomized trials have raised serious concern about the potential kidney-related toxic effects of HES leading to greater utilization of renal replacement therapy (RRT). 9,[13][14][15] There has been suggestion that HES solutions with a lower molecular weight and a lower degree of molar substitution have an improved safety profile with regard to bleeding complications and acute kidney injury (AKI); however, findings have been inconsistent. 9,10,[16][17][18][19][20] Experimental data have shown that these newer generation HES solutions can still accumulate in tissues within six hours of administration, including in the liver, kidney, lung, spleen, and lymph nodes.…”

Section: Commentarymentioning

confidence: 99%

“…These findings appear to confirm the increased risk of toxicity evident in prior trials focused on critically ill patients with sepsis. 13,15 Moreover, the observed hazard of death with HES was delayed (30-90 days), implying that prior trials of HES with short-term follow-up may not have been able to detect the risk.…”

Section: Commentarymentioning

confidence: 99%

Hydroxyethyl starch for fluid resuscitation in critically ill patients

Bagshaw

Chawla

2013

Can J Anesth/J Can Anesth

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Article appraisedMyburgh JA, Finfer S, Bellomo R, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012: 367: 1901-11. Structured AbstractBackground: Intravenous fluid therapy is one of the most frequent interventions provided to patients in the intensive care unit; however, the type of fluid (i.e., crystalloid or colloid) used for resuscitation remains controversial. The most common type of colloid administered to resuscitate critically ill patients is hydroxyethyl starch (HES); however, its safety and efficacy have not been rigorously evaluated in large pragmatic randomized trials, and emerging data have accumulated to question its potential for toxic adverse effects.Objective: To evaluate the efficacy and safety of HES for fluid resuscitation in critically ill patients with a focus on survival and kidney function.

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A Systematic Review of the Comparative Safety of Colloids

2004

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Hypothesis: Safety differences exist among colloids widely used for fluid management in acutely ill patients, as judged according to the comparative incidence of adverse events.Data Sources: Colloid safety data for human subjects were sought, without language or time period restrictions, by means of computer searches of bibliographic and clinical trial databases, hand searches of medical journals and Index Medicus, inquiries with investigators and colloid suppliers, and examination of reference lists. Search terms included "colloids", "morbidity", and "mortality".Study Selection: Controlled trials, cohort studies, pharmacovigilance studies, and prior meta-analyses were independently selected by 2 unblinded investigators. Of 189 candidate studies, 113 were included, with safety data encompassing 1.54 ϫ 10 6 patients and 1.09 ϫ 10 8 colloid infusions.Data Extraction: Two unblinded investigators independently extracted data. Study limitations and confounding factors were tabulated.

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Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study

Cited by 688 publications

References 32 publications

Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

Hydroxyethyl starch for fluid resuscitation in critically ill patients

A Systematic Review of the Comparative Safety of Colloids

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