6/30/23, 12:37 AM VISEP Pathway Feedback Search Clinical Topics Home Studies VISEP VISEP Disease Sepsis and septic shock Trial question Is intensive insulin therapy superior to conventional insulin therapy in critically ill patients with sepsis? Study design Multi-center Open label RCT Population Characteristics of study participants 40.0% female N = 537 60.0% male 537 patients (215 female, 322 male) Inclusion criteria: adult patients with severe sepsis or septic shock Key exclusion criteria: age < 18 years; pre-existing kidney failure requiring dialysis; intracerebral hemorrhage; severe head trauma with edema; HF Interventions N=247 intensive insulin therapy (blood glucose target 80-110 mg/dL) N=290 conventional insulin therapy (blood glucose target 180-200 mg/dL) Primary outcome Death at day 28 26.0 % 26 24.7 19.5 % https://web.pathway.md/studies/recawpTsrLbYJKZ49 1/2 6/30/23, 12:37 AM VISEP Pathway 13.0 % 6.5 % No significant difference 0.0 % Intensive insulin therapy Conventional insulin therapy No significant difference in death at day 28 (24.7% vs. 26%; ARD -1.3, 95% CI -8.6 to 6) Secondary outcomes No significant difference in death at day 90 (39.7% vs. 35.4%; AD 4.3%, 95% CI -3.93 to 12.53) No significant difference in mean sequential organ failure assessment score (7.8 vs. 7.7; MD 0.1, 95% CI -1.1 to 1.3) No significant difference in acute renal failure (31.1% vs. 26.6%; AD 4.5%, 95% CI -3.12 to 12.12) Safety outcomes Significant differences in severe hypoglycemia (17.0% vs. 4.1%), serious adverse events (10.9% vs. 5.2%). Conclusion In adult patients with severe sepsis or septic shock, intensive insulin therapy was not superior to conventional insulin therapy with respect to death at day 28. Reference Frank M Brunkhorst, Christoph Engel, Frank Bloos et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. Open reference URL https://web.pathway.md/studies/recawpTsrLbYJKZ49 2/2