LEUVEN-2
Trial question
Is intensive insulin therapy superior to conventional insulin therapy in medical ICU patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.6% female
61.4% male
N = 1200
1200 patients (462 female, 738 male).
Inclusion criteria: patients who have a need for intensive care for at least three days.
Key exclusion criteria: being in a surgical ICU; able to receive oral nutrition; under DNR orders.
Interventions
N=595 intensive insulin therapy (blood glucose target 80-110 mg/dL).
N=605 conventional insulin therapy (blood glucose target 180-200 mg/dL).
Primary outcome
Hospital death
40%
37.3%
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Intensive insulin
therapy
Conventional insulin
therapy
No significant
difference ↔
No significant difference in hospital death (40% vs. 37.3%; AD 2.7%, 95% CI -2.68 to 8.08).
Secondary outcomes
Significant decrease in the rate of hospital death in patients who stayed in the ICU for ≥ 3 days (43% vs. 52.5%; ARD -9.5, 95% CI -16.63 to -2.37).
Significantly lower reduction in newly acquired kidney injury (5.9% vs. 8.9%; ARD -3, 95% CI -5.87 to -0.13).
No significant difference in death from any cause at day 90 (35.9% vs. 37.7%; ARD -1.8, 95% CI -7.27 to 3.67).
Conclusion
In patients who have a need for intensive care for at least three days, intensive insulin therapy was not superior to conventional insulin therapy with respect to hospital death.
Reference
Greet Van den Berghe, Alexander Wilmer, Greet Hermans et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61.
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