Leuven I Brief Summary – Intensive insulin therapy in the SICU

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Summary of the Leuven I (van den Berghe 2002) Trial

In surgical ICU patients (primarily cardiac), intensive insulin therapy reduced ICU mortality, renal impairment, and bloodstream infections. The rate of severe hypoglycemia was higher with intensive insulin.

Key Points from Leuven I (van den Berghe 2002)

  • Included 1548 patients admitted to a surgical ICU (primarily cardiac) receiving mechanical ventilation
  • Randomized patients to intensive insulin (BG goal 80-110 mg/dL) or conventional insulin (BG < 215 mg/dL)
  • Study protocol was conducted by a team that was not involved in the daily management of each patient (limits external validity)
  • Primary endpoint (ICU mortality) was higher with conventional therapy (8% vs. 4.6%, p<0.04, NNT 29). Hospital mortality was also higher (10.9% vs. 7.2%, p=0.01, NNT 27)
    Average morning blood glucose was lower (as expected) with intensive control (153 vs. 103 mg/dL)
  • Intensive therapy was associated with a reduction in renal impairment (both SCr > 2.5 mg/dL and need for renal replacement therapy), bloodstream infections, and the number of RBC transfusions per patient
  • There was no difference in ICU length of stay or duration of mechanical ventilation
    Hypoglycemia (BG < 40 mg/dL) occurred more frequently with intensive insulin (5% vs. 0.8%, NNH 24). Note that subsequent studies have suggested hypoglycemic rates that are much higher.


van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. PMID 11794168

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