Abstract | BACKGROUND: Hydroxyethyl starch (HES) is used for fluid replacement in millions of patients around the world every year, yet it has been found to have adverse effects that have a negative impact on patient survival. Recent clinical trials with a modern HES solution (HES 130) and meta-analyses now enable a reassessment of its risks and benefits. METHODS: On the basis of a selective literature search focusing on reports of the use of HES 130/0.4 and HES 130/0.42 in sepsis, trauma, and intensive care medicine, data from randomized controlled trials (RCTs) are presented, and up-to-date meta-analyses and reviews are discussed. Moreover, the authors conducted an independent meta-analysis of HES 130 in comparison to crystalloids or albumin in intensive care medicine, sepsis, and trauma. RESULTS: Seven RCTs were evaluated, involving a total of 7838 patients treated for sepsis or trauma, or in intensive care. HES 130 was associated with a higher cumulative risk of death (relative risk [RR] 1.10, 95% confidence interval [CI] 1.01-1.20), more frequent need for a renal replacement procedure (RR 1.26, 95% CI 1.08-1.46), and more frequent need for blood transfusion (RR 1.22, 95% CI 1.08-1.37). There was no patient-relevant benefit. Four recent meta-analyses of data from a total of more than 10 000 patients confirmed these concerns about the safety of HES in general and, in particular, of low-molecular-weight HES 130 for patients in intensive care. The safety of 6% HES 130 in the immediate perioperative period has not been adequately demonstrated. DISCUSSION: Because of safety concerns, fluid replacement with HES in critically ill patients cannot be recommended. Evidence for its superior efficacy, safety and cost effectiveness in preoperative use is also lacking.
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Authors | Christiane S Hartog, Tobias Welte, Peter Schlattmann, Konrad Reinhart |
Journal | Deutsches Arzteblatt international
(Dtsch Arztebl Int)
Vol. 110
Issue 26
Pg. 443-50
(Jun 2013)
ISSN: 1866-0452 [Electronic] Germany |
PMID | 23885279
(Publication Type: Comparative Study, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't, Review)
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Chemical References |
- Albumins
- Crystalloid Solutions
- Hydroxyethyl Starch Derivatives
- Isotonic Solutions
- Plasma Substitutes
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Topics |
- Albumins
(therapeutic use)
- Critical Care
(statistics & numerical data)
- Critical Illness
(mortality, therapy)
- Crystalloid Solutions
- Evidence-Based Medicine
- Fluid Therapy
(mortality)
- Humans
- Hydroxyethyl Starch Derivatives
(therapeutic use)
- Isotonic Solutions
(therapeutic use)
- Plasma Substitutes
(therapeutic use)
- Risk Factors
- Sepsis
(mortality, therapy)
- Survival Analysis
- Survival Rate
- Treatment Outcome
- Wounds and Injuries
(mortality, therapy)
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