Strict glycemic control in patients hospitalized in a mixed medical and surgical intensive care unit: a randomized clinical trial.
Crit Care. 2008 Sep 17;12(5):R120
Authors: De La Rosa GD, Donado JH, Restrepo AH, Quintero AM, Gonzalez LG, Saldarriaga NE, Bedoya MT, Toro JM, Velasquez JB, Valencia JC, Arango CM, Aleman PH, Vasquez EM, Chavarriaga JC, Yepes A, Pulido W, Cadavid CA
ABSTRACT: INTRODUCTION: Critically ill patients develop hyperglycemia even though they are not diabetics. Intensive insulin therapy (IIT) decreases morbidity and mortality in patients in a surgical intensive care unit (ICU) and decreases morbidity in patients in a medical ICU. The effect of this therapy in patients on a mixed medical/surgical ICU is unknown. Our goal was to assess whether the effect of IIT, compared to standard therapy, decreases morbidity and mortality in patients hospitalized in a mixed ICU. METHODS: Prospective, randomized, non-blinded, single-center clinical trial in a medical/surgical ICU. Patients were randomly assigned to receive either IIT to maintain glucose levels between 80 - 110 mg/dl (4.4 - 6.1 mmol per liter), or standard insulin therapy (SIT) to maintain glucose levels between 180 - 200 mg/dl (10 - 11.1 mmol per liter). The primary end point was 28-day mortality. RESULTS: 504 patients were enrolled in a period of 30 months. The 28-day mortality rate was 32.4 % (81/250) in the SIT group and 36.6 % (93/254) in the IIT group (Relative Risk [RR]: 1.1; 95% confidence interval [95%CI]: 0.85 - 1.42). The ICU mortality in the SIT group was 31.2% (78/250) and 33.1% (84/254) in the IIT group (RR: 1.06; 95%CI: 0.82 - 1.36). There was no statistically significant reduction in the rate of ICU-acquired infections: 33.2% in the SIT group versus 27.17% in the IIT group (RR: 0.82; 95%CI: 0.63 - 1.07). The rate of hypoglycemia ([less than or equal to]40mg/dl) was 1.7% in the SIT group and 8.5% in the IIT group (RR: 5.04; 95% CI: 1.20 - 21.12). CONCLUSIONS: IIT used to maintain glucose levels within normal limits did not reduce morbidity nor mortality of patients admitted to a medical/surgical ICU. Furthermore, this therapy increased the risk of hypoglycemia. Trial Registration clinicaltrials.gov Identifiers: 4374-04-13031; 094-2 in 000966421.
PMID: 18799004 [PubMed - as supplied by publisher]