Jason M. Elinoff, MD; Robert L. Danner, MD
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?
Randomized controlled trial (RCT) (Scandinavian Starch for Severe Sepsis/Septic Shock [6S] trial). ClinicalTrials.gov NCT00962156.
Blinded* (patients, clinicians, research staff, safety committee, manuscript writers, and statisticians).
26 intensive care units (ICUs) in Denmark, Norway, Finland, and Iceland.
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.
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.
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).
99% (modified intention-to-treat analysis).
The main results are in the Table.
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†
†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.
Elinoff JM, Danner RL. Hydroxyethyl starch 130/0.42 increased death at 90 days compared with Ringer's acetate in severe sepsis. Ann Intern Med. ;157:JC4–6. doi: 10.7326/0003-4819-157-8-201210160-02006
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Published: Ann Intern Med. 2012;157(8):JC4-6.
Multi-Organ Failure and Sepsis, Pulmonary/Critical Care.
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