CONTRA: Hydroxyethyl starch solutions are unsafe in critically ill patients
- 332 Downloads
To describe the risk–benefit profile of hydroxyethyl starch (HES).
(1) Efficacy: no single clinical study or systemic review has shown that administration of any HES solution confers a clinically relevant benefit compared to crystalloids in critically ill patients or surgical patients in need of volume replacement. Contrary to beliefs expecting a ratio of 4:1 or more for crystalloid to colloid volume need, recent studies of goal-directed resuscitation observed much lower ratios of between 1 and 1.6. (2) Safety: HES administration is associated with coagulopathy, nephrotoxicity, pruritus and increased long-term mortality. Clinical studies claiming that modern HES 130/0.4 is safe have serious methodological drawbacks and do not adequately address the safety concerns.
Given the complete lack of superiority in clinical utility studies and the wide spectrum of severe side effects, the use of HES in the ICU should be stopped. The belief that four times as much crystalloid as colloid fluid volume is needed for successful resuscitation is being seriously questioned.
KeywordsColloids Crystalloids Hydroxyethyl starch Efficacy Safety Critically ill
No funding was obtained in support of this analysis. The authors have in the past received unrestricted funding from B. Braun, Melsungen, for the conduct of the VISEP study.
Conflict of interest statement
The authors report no current conflict of interest.
- 1.Perel P, Roberts I (2007) Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev (Online):CD000567Google Scholar
- 4.Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K (2008) Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 358:125–139PubMedCrossRefGoogle Scholar
- 11.FDA, Center for Biologics Evaluation and Research (2007) Product approval information––new drug applications. NDA review memo (mid-cycle) http://www.fda.gov/CbER/nda/voluven.htm. Accessed 10 Sept 2008
- 14.Klemm E, Bepperling F, Burschka MA, Mosges R (2007) Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients. Otol Neurotol 28:157–170PubMedCrossRefGoogle Scholar
- 15.Ganzevoort W, Rep A, Bonsel GJ, Fetter WP, van Sonderen L, De Vries JI, Wolf H (2005) A randomised controlled trial comparing two temporising management strategies, one with and one without plasma volume expansion, for severe and early onset pre-eclampsia. BJOG 112:1358–1368PubMedCrossRefGoogle Scholar
- 18.Verheij J, van Lingen A, Raijmakers PG, Rijnsburger ER, Veerman DP, Wisselink W, Girbes AR, Groeneveld AB (2006) Effect of fluid loading with saline or colloids on pulmonary permeability, oedema and lung injury score after cardiac and major vascular surgery. Br J Anaesth 96:21–30PubMedCrossRefGoogle Scholar
- 35.Kasper SM, Meinert P, Kampe S, Gorg C, Geisen C, Mehlhorn U, Diefenbach C (2003) Large-dose hydroxyethyl starch 130/0.4 does not increase blood loss and transfusion requirements in coronary artery bypass surgery compared with hydroxyethyl starch 200/0.5 at recommended doses. Anesthesiology 99:42–47PubMedCrossRefGoogle Scholar
- 45.Fenger-Eriksen C, Hartig Rasmussen C, Kappel Jensen T, Anker-Moller E, Heslop J, Frokiaer J, Tonnesen E (2005) Renal effects of hypotensive anaesthesia in combination with acute normovolaemic haemodilution with hydroxyethyl starch 130/0.4 or isotonic saline. Acta Anaesthesiol Scand 49:969–974PubMedCrossRefGoogle Scholar