title: Fluid resuscitation with 6% hydroxyethyl starch (130/0.4) in acutely ill patients: an updated systematic review and meta-analysis.
abstract: BACKGROUND
  Recent research suggests that 6% hydroxyethyl starch (HES) 130/0.4 is one of the most frequently used resuscitation fluids worldwide. The retraction of studies evaluating its use necessitates a reevaluation of available evidence regarding its safety and efficacy.
  
  
  METHODS
  We performed a systematic review and meta-analysis of unretracted randomized controlled trials comparing the effects of 6% HES 130/0.4 with other colloid or crystalloid solutions on mortality, acute kidney injury/failure, and bleeding in acutely ill or perioperative patients. A sensitivity analysis including the data from retracted studies was also conducted.
  
  
  RESULTS
  Overall, 36 studies reporting 2149 participants met the inclusion criteria, of which 11 (n = 541) have been retracted. Of the remaining 25 studies, there was a high risk of bias in 17 studies; 19 studies (n = 1246) were conducted in perioperative patients and 6 (n = 362) in critically ill patients. Sixteen studies reported mortality: 104 deaths in 1184 participants. The relative risk of death was 0.95 (95% confidence interval 0.64-1.42, I(2) = 0%, P = 0.73); including the retracted studies added a further 14 deaths and the relative risk was 0.92 (95% confidence interval 0.63-1.34, I(2) = 0%, P = 0.95). The data reporting acute kidney injury, red blood cell transfusion, and bleeding were of insufficient quantity and quality and not amenable to meta-analysis.
  
  
  CONCLUSIONS
  Published studies are of poor quality and report too few events to reliably estimate the benefits or risks of administering 6% HES 130/0.4. This same conclusion is reached with or without the retracted studies. Given the widespread use of 6% HES 130/0.4, high-quality trials reporting a large number of events are urgently required.
authors.affiliation: Critical Care & Trauma Division, The George Institute for Global Health, University of Sydney, Australia. dgattas@med.usyd.edu.a
authors.forename: David J
authors.initials: DJ
authors.lastname: Gattas
authors.forename: Arina
authors.initials: A
authors.lastname: Dan
authors.forename: John
authors.initials: J
authors.lastname: Myburgh
authors.forename: Laurent
authors.initials: L
authors.lastname: Billot
authors.forename: Serigne
authors.initials: S
authors.lastname: Lo
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D016638:Critical Illness; D019317:Evidence-Based Medicine; D005440:Fluid Therapy / Q000009:adverse effects / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000009:adverse effects; D010952:Plasma Substitutes / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D012151:Resuscitation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes