A phase II randomised controlled trial of intensive insulin therapy in general intensive care patients
ABSTRACT
Objective: To determine the safety and efficacy ofan intensive insulin regimen compared with aconventional insulin regimen in general intensivecare unit patients.
Methods: A phase II, randomised controlled trial wasconducted in 70 critically ill patients in a closedmulti disciplinary ICU of a university-affiliated tertiaryhospital. We assessed patient characteristics at baseline.Trial process measures included number of blood glucose measurements per day and number in target range, typeand quantity of caloric intake, patient outcome and insulindosing. The primary outcome was the median bloodglucose concentration. Secondary outcome measures were incidence of hypoglycaemia (blood glucose level< 2.2 mmol/L), clinical sequelae of hypoglycaemia andhospital mortality.
Results: Thirty-five patients were randomised to each ofthe two groups. More blood glucose samples were takenper day in the intensive insulin group (16 versus 9), but thenumber of samples in the normoglycaemic range was48.5%, compared with 79.8% within the target glucoserange in the conventional insulin group. The median (interquartile range) blood glucose concentrations in theintensive and conventional insulin therapy groups were5.4 (5.1-5.7) mmol/L and 7.9 (7.2-9.0) mmol/L,respectively (difference, 2.5mmol/L; P < 0.0001). Fivepatients (14.3%) in the intensive insulin therapy group became hypoglycaemic versus none in the conventional insulin therapy group. There were no detected clinicalsequelae of hypoglycaemia.
Conclusion: The intensive insulin regimen was effective inachieving the target blood glucose concentration, with clear separation from the conventional insulin regimen. Althoughthe incidence of hypoglycaemia was increased, there wasno detectable harm.
Crit Care Resusc 2006; 8: 289-293
