6/30/23, 12:53 AM 6S Pathway Feedback Search Clinical Topics Home Studies 6S 6S Disease Sepsis and septic shock Trial question What is the role of hydroxyethyl starch 130/0.42 fluid resuscitation in patients with severe sepsis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 39.4% female N = 804 60.6% male 804 patients (315 female, 483 male) Inclusion criteria: ICU patients with severe sepsis Key exclusion criteria: age < 18 years old, receipt of > 1,000 mL of synthetic colloid, RRT, acute burn injury > 10% BSA, severe hyperkalemia, liver or kidney transplantation, intracranial bleeding Interventions N=398 HES 130/0.42 (6% hydroxyethyl starch 130/0.42, Tetraspan) N=400 Ringer's lactate (at a dose of up to 33 mL/kg of ideal body weight per day) Primary outcome Death or end-stage kidney failure at 90 days 51 51.0 % 43 https://web.pathway.md/studies/recO6n2Ve3esCiuBA 1/2 6/30/23, 12:53 AM 6S Pathway 38.3 % 25.5 % Significant increase 12.8 % NNH = 13 0.0 % HES 130/0.42 Ringer's lactate Significant increase in death or end-stage kidney failure at 90 days (51% vs. 43%; RR 1.17, 95% CI 1.01 to 1.36) Secondary outcomes No significant difference in death at day 28 (39% vs. 36%; RR 1.08, 95% CI 0.9 to 1.28) No significant difference in severe bleeding (10% vs. 6%; RR 1.52, 95% CI 0.94 to 2.48) No significant difference in renal-replacement therapy or renal Sequential Organ Failure Assessment score 3 (32% vs. 27%; RR 1.2, 95% CI 0.97 to 1.48) Safety outcomes No significant differences in severe allergic reaction, acidosis, doubling of plasma creatinine level. Significant difference in use of renal-replacement therapy (22% vs. 16%). Conclusion In ICU patients with severe sepsis, HES 130/0.42 was not superior to Ringer's lactate with respect to death or end-stage kidney failure at 90 days. Reference Anders Perner, Nicolai Haase, Anne B Guttormsen et al. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. Open reference URL https://web.pathway.md/studies/recO6n2Ve3esCiuBA 2/2