Document Detail


Hydroxyethyl starch 130/0.42 increased death at 90 days compared with Ringer's acetate in severe sepsis.
MedLine Citation:
PMID:  23070508     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
QUESTION In adults with severe sepsis, what are the relative efficacy and safety of hydroxyethyl starch (HES) 130/0.42 and Ringer's acetate for fluid resuscitation? METHODS DESIGN Randomized controlled trial (RCT) (Scandinavian Starch for Severe Sepsis/Septic Shock [6S] trial). ClinicalTrials.gov NCT00962156. ALLOCATION Concealed.* BLINDING Blinded* (patients, clinicians, research staff, safety committee, manuscript writers, and statisticians). FOLLOW-UP PERIOD 90 days. SETTING 26 intensive care units (ICUs) in Denmark, Norway, Finland, and Iceland. PATIENTS 804 ICU patients ≥ 18 years of age (median age 67 y, 61% men) who had severe sepsis (defined focus of infection and ≥ 2 systemic inflammatory response syndrome criteria) in the previous 24 hours and needed fluid resuscitation. Exclusion criteria included > 1000 mL of synthetic colloid in the previous 24 hours; renal replacement therapy; acute burn injury to > 10% of body surface; severe hyperkalemia; or liver or kidney transplantation or intracranial bleeding during current hospitalization. INTERVENTION 6% HES 130/0.42 in Ringer's acetate (Tetraspan 6%, B Braun) (n = 400) or Ringer's acetate (Sterofundin ISO, B Braun) (n = 400) to a maximum daily dose of 33 mL/kg ideal body weight administered intravenously for ≤ 90 days. OUTCOMES Primary outcome was a composite of death or dependence on dialysis (any renal replacement therapy from 86 to 94 d after randomization) at 90 days. Secondary outcomes included components of the composite endpoint, any renal replacement therapy, and severe bleeding (≥ 3 units of packed red cells within 24 h). PATIENT FOLLOW-UP 99% (modified intention-to-treat analysis). MAIN RESULTS The main results are in the Table. CONCLUSION In patients with severe sepsis needing fluid resuscitation, hydroxyethyl starch 130/0.42 increased death at 90 days and need for renal replacement therapy compared with Ringer's acetate.Hydroxyethyl starch (HES) 130/0.42 vs Ringer's acetate for fluid resuscitation in patients with severe sepsis†OutcomesEvent ratesAt 90 dHESRinger's acetateRRI (95% CI)NNH (CI)Death or dependence on dialysis‡51%43%17% (1 to 36)14 (7 to 232)Death51%43%17% (1 to 36)14 (7 to 233)Any renal replacement therapy22%16%35% (1 to 80)18 (8 to 616)Severe bleeding§10%6%52% (-6 to 148)NS†NS = not significant; other abbreviations defined in Glossary. RRI, NNH, and CI calculated from control event rates and relative risks in article.‡1 patient in each group was dependent on dialysis at 90 days.§≥ 3 units of packed red cells within 24 h.
Authors:
Jason M Elinoff; Robert L Danner
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  157     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC4-6     Citation Subset:  AIM; IM    
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