COIITSS
Trial question
Is intensive insulin therapy superior to conventional insulin therapy in patients treated with hydrocortisone for septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 509
509 patients (179 female, 330 male)
Inclusion criteria: adult patients with septic shock who were treated with hydrocortisone
Key exclusion criteria: pregnancy; life expectancy below 24 hours
Interventions
N=255 intensive insulin therapy (continuous insulin infusion to maintain blood glucose levels between 4-6 mmol/L plus hydrocortisone 50 mg intravenous bolus every 6 hours for 7 days)
N=254 conventional insulin therapy (conventional glycemic control plus hydrocortisone 50 mg intravenous bolus every 6 hours for 7 days)
Primary outcome
Death in hospital
45.9
42.9
45.9 %
34.4 %
22.9 %
11.5 %
0.0 %
Intensive insulin
therapy
Conventional insulin
therapy
No significant
difference ↔
No significant difference in death in the hospital (45.9% vs. 42.9%; RR 1.07, 95% CI 0.88 to 1.3)
Secondary outcomes
Borderline significant increase in median vasopressor-free days at 7 days (4 days vs. 4 days; )
No significant difference in median mechanical ventilation-free days within 28 days (10 days vs. 13 days; MD -3, 95% CI -11.71 to 5.71)
No significant difference in SOFA score < 8 at day 7 (64.3% vs. 60.6%; AD 3.7%, 95% CI -4.45 to 11.85)
Safety outcomes
No significant difference in superinfections.
Significant difference in severe hypoglycemia (16.4% vs. 7.8%).
Conclusion
In adult patients with septic shock who were treated with hydrocortisone, intensive insulin therapy was not superior to conventional insulin therapy with respect to death in the hospital.
Reference
COIITSS Study Investigators, Djillali Annane, Alain Cariou et al. Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):341-8.
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