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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,069
On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).
Hôpital Nord Franche Comte
Belfort, France
CH de Bourg-en-Bresse
Bourg-en-Bresse, France
Centre Hospitalier de Bourgoin-Jallieu
Bourgoin, France
CH Chartres
Chartres, France
CHU de Clermont Ferrand - Gabriel Montpied
Clermont-Ferrand, France
CHU de Dijon - Complexe Hospitalier du Bocage
Dijon, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU de Nice - Hôpital de l'Archet 1
Nice, France
CH de Polynésie Française
Papeete, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, France
...and 2 more locations
All-cause mortality
Time frame: 90 days after randomization
All-cause mortality
Time frame: 28 days after randomization and at ICU discharge
Length of intensive care unit stay
Time frame: 90 days
Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
Time frame: during ICU stay (on average 10 days)
incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
Time frame: during ICU stay (on average 10 days)
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