Hydroxyeyhyl starch: Controversies revisited

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Abstract

Hydroxyethyl starch (HES) family has been one of the cornerstones in fluid management for over four decades. Recent evidence from clinical studies and meta-analyses has raised few concerns about the safety of these fluids, especially in certain subpopulations of patients. High-quality clinical trials and meta-analyses have emphasized nephrotoxic effects, increased risk of bleeding, and a trend toward higher mortality in these patients after the use of HES solutions. Scientific evidence was derived from international guidelines, aggregated research literature, and opinion-based evidence was obtained from surveys and other activities (e.g., internet postings). On critical analysis of the current data available, it can be summarized that further large scale trials are still indicated before HES can be discarded.

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Most cited references 86

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Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial.

Djillali Annane (2013)

Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear. To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock. A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012. Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay. The primary outcome was death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy. Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, -0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, -0.04 to 2.10] days; P = .03). Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy. clinicaltrials.gov Identifier: NCT00318942.

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

F Lemaire, I Cattaneo, M. Mamzer-Bruneel … (2001)

Hydroxyethylstarch used for volume restoration in brain-dead kidney donors has been associated with impaired kidney function in the transplant recipients. We undertook a multicentre randomised study to assess the frequency of acute renal failure (ARF) in patients with severe sepsis or septic shock treated with hydroxyethylstarch or gelatin. Adults with severe sepsis or septic shock were enrolled prospectively in three intensive-care units in France. They were randomly assigned 6% hydroxyethylstarch (200 kDa, 0.60-0.66 substitution) or 3% fluid-modified gelatin. The primary endpoint was ARF (a two-fold increase in serum creatinine from baseline or need for renal replacement therapy). Analyses were by intention to treat. 129 patients were enrolled over 18 months. Severity of illness and serum creatinine (median 143 [IQR 88-203] vs 114 [91-175] micromol/L) were similar at baseline in the hydroxyethylstarch and gelatin groups. The frequencies of ARF (27/65 [42%] vs 15/64 [23%], p=0.028) and oliguria (35/62 [56%] vs 23/63 [37%], p=0.025) and the peak serum creatinine concentration (225 [130-339] vs 169 [106-273] micromol/L, p=0.04) were significantly higher in the hydroxyethylstarch group than in the gelatin group. In a multivariate analysis, risk factors for acute renal failure included mechanical ventilation (odds ratio 4.02 [95% CI 1.37-11.8], p=0.013) and use of hydroxyethylstarch (2.57 [1.13-5.83], p=0.026). The use of this preparation of hydroxyethylstarch as a plasma-volume expander is an independent risk factor for ARF in patients with severe sepsis or septic shock.

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Hydroxyethyl starches: different products--different effects.

Martin Westphal, Michael F M James, Sibylle Kozek-Langenecker … (2009)

With the development of a new generation of hydroxyethyl starches (HES), there has been renewed interest in their clinical potential. High doses of first- and second-generation HES were associated with adverse effects on renal function, coagulation, and tissue storage, thereby limiting their clinical applicability. Newer HES products have lower molar substitution and in vivo molecular weight, resulting in more rapid metabolism and clearance. In this review article, the differences between HES generations are highlighted, with particular emphasis on the improved safety profile of the third generation products. These improvements have been achieved with no loss of efficacy, and they contradict the assumption that efficacy of HES solutions is directly linked to plasma concentration. The impact of source material on structure and pharmacokinetics is highlighted, and the role of the carrier solution is critically assessed.

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Author and article information

Journal

Journal ID (nlm-ta): J Anaesthesiol Clin Pharmacol

Journal ID (iso-abbrev): J Anaesthesiol Clin Pharmacol

Journal ID (publisher-id): JOACP

Title: Journal of Anaesthesiology, Clinical Pharmacology

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 0970-9185

ISSN (Electronic): 2231-2730

Publication date (Print): Oct-Dec 2014

Volume: 30

Issue: 4

Pages: 472-480

Affiliations

[1]Department of Anaesthesiology & Critical Care, Army Hospital (R & R), Delhi Cantonment, India

Author notes

Address for correspondence: Dr. Col. Rashmi Datta, Department of Anaesthesiology & Critical Care, Army Hospital (R & R), Delhi Cantonment, India. E-mail: drrashmidatta@ 123456gmail.com

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Publisher ID: JOACP-30-472

DOI: 10.4103/0970-9185.142801

PMC ID: 4234780

PubMed ID: 25425769

SO-VID: 35e281f3-892d-4490-b784-78718a66a7f6

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This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Hydroxyeyhyl starch: Controversies revisited

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Irish Journal of Paramedicine

Most cited references 86

Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial.

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

Hydroxyethyl starches: different products--different effects.

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