VISEP
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
60.0% male
N = 537
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
24.7
26
26.0 %
19.5 %
13.0 %
6.5 %
0.0 %
Intensive insulin
therapy
Conventional insulin
therapy
No significant
difference ↔
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 SOFA score (7.8 points vs. 7.7 points; 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.
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