title: Starch safety in resuscitation - when will we ever learn?
abstract: Recent trials have failed to demonstrate a survival benefit from the use of hydroxyethyl starches (HES) as a colloid in fluid resuscitation and have raised concerns of renal harm. In severe sepsis, there is a concerning signal of increased mortality. New high-quality systematic reviews consistently demonstrate a statistically non-significant relative risk of death of 1.08 - 1.10 and a significant 25% increased chance of requiring renal replacement therapy. The HES literature contains many industry-affiliated reviews of indifferent quality. Traditional efficacy confidence limits may warrant re-evaluation when considering these harms. Newer formulations of HES and more focused indications for use show benefit on surrogate endpoints, but these trials are currently underpowered to ensure safety.
authors.affiliation: Department of Internal Medicine, Frere and Cecilia Makiwane Hospitals, East London, South Africa. andygp@mweb.co.za
authors.forename: Andy
authors.initials: A
authors.lastname: Parrish
authors.forename: Marc
authors.initials: M
authors.lastname: Blockman
mesh_terms: D002986:Clinical Trials as Topic; D003102:Colloids; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000627:therapeutic use*; D061214:Patient Safety; D010952:Plasma Substitutes / Q000627:therapeutic use*; D012151:Resuscitation / Q000379:methods*; D018805:Sepsis / Q000628:therapy
chemical_list: D003102:Colloids; D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes