Leuven Surgical Trial
Trial question
Is intensive insulin therapy superior to conventional treatment in critically ill patients?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 1548
1548 patients (447 female, 1101 male).
Inclusion criteria: adult patients admitted to surgical ICU who were receiving mechanical ventilation.
Key exclusion criteria: participation in other trials, moribund, or DNR orders.
Interventions
N=765 intensive insulin therapy (maintenance of blood glucose at a level between 80 and 110 mg/dL).
N=783 conventional treatment (infusion of insulin only if the blood glucose level exceeded 215 mg/dL and maintenance of glucose at a level between 180 and 200 mg/dL).
Primary outcome
Death
4.6%
8%
8.0 %
6.0 %
4.0 %
2.0 %
0.0 %
Intensive insulin
therapy
Conventional
treatment
Significant
decrease ▼
NNT = 29
Significant decrease in death (4.6% vs. 8%; RR 0.58, 95% CI 0.38 to 0.78).
Secondary outcomes
Significant decrease in death in the hospital (7.2% vs. 10.9%; RR 0.66, 95% CI 0.16 to 1.16).
Borderline significant increase in duration of intensive care (3 days vs. 3 days).
Significant decrease in the rate of prolonged ventilatory support for > 14 days (7.5% vs. 11.9%; RR 0.63, 95% CI 0.21 to 1.05).
Safety outcomes
No significant differences in red cell transfusion, inotropic or vasopressor treatment.
Significant differences in dialysis or continuous venovenous hemofiltration (4.8% vs. 8.2%), septicemia during intensive care (4.2% vs. 7.8%), critical-illness polyneuropathy (28.7% vs. 51.9%).
Conclusion
In adult patients admitted to surgical ICU who were receiving mechanical ventilation, intensive insulin therapy was superior to conventional treatment with respect to death.
Reference
G van den Berghe, P Wouters, F Weekers et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.
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