Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.
Status:
Terminated
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
During the last 2 decades, the management of hyperglycemia in critically ill patients has
become one of the most discussed topics in the intensive-care field. The initial data
suggesting significant benefit from the normalization of blood glucose levels in critically
ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J
Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some
studies suggested that strict blood glucose control might benefit in non-diabetic patient and
worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target
based on glycated hemoglobin measured at ICU admission would improve outcome when compared to
a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a
randomized double blinded study in which Blood glucose control is piloted in both groups by a
web-guided protocol that directly gives instruction to nurses
(https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.
Primary end point is 90 d outcome after randomization.