title: Randomised trials of 6% tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis.
abstract: OBJECTIVE
  To assess the impact of 6% tetrastarch [hydroxyethyl starch (HES) 130/0.4 and 130/0.42] in severe sepsis patients. The primary outcome measure was 90-day mortality.
  
  
  METHODS
  A structured literature search was undertaken to identify prospective randomised controlled trials (RCTs) in adult patients with severe sepsis receiving 6% tetrastarch (of potato or waxy maize origin) as part of fluid resuscitation in comparison with other non-HES fluids after randomisation in the critical care setting. A systematic review and meta-analysis were performed.
  
  
  RESULTS
  Six RCTs were included (n = 3,033): three from 2012 (n = 2,913) had low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30-43 ml/kg). Ninety-day mortality was associated with tetrastarch exposure [relative risk (RR) 1.13; 95% confidence interval (CI) 1.02-1.25; p = 0.02] compared with crystalloid. The number needed to harm (NNH) was 28.8 (95 % CI 14.6-942.5). Publication bias and statistical heterogeneity (I(2) = 0%) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, for comparison with colloid as control, or for waxy maize-derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95% CI 1.02-1.25; p = 0.02).
  
  
  CONCLUSIONS
  In our analysis, 6% tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm and, as alternatives exist, in our view should be avoided.
authors: Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK. amit.patel@imperial.ac.uk
authors: Amit
authors: A
authors: Patel
authors: Umeer
authors: U
authors: Waheed
authors: Stephen J
authors: SJ
authors: Brett
mesh_terms: D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000009:adverse effects*; D010952:Plasma Substitutes / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D018805:Sepsis / Q000401:mortality* / Q000628:therapy*
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes