Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients. It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity. The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients. Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.
The phase II of the study will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (CABG) surgery. A nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned CABG surgery. The aim of the phase III of the study will compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned CABG surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Post operative intensive care unit of the cardiac surgery department
Besançon, France
Percentage of patients spending more than 50 % of the time in the glycemic target range (100 to 140 mg/dl)
The percentage of time spent achieving blood glucose control is defined as the ratio between the total time spent achieving blood glucose control and the total time under treatment. Blood glucose measurement will be done hourly. Blood glucose control is considered to be achieved between 2 blood glucose measurements if the first blood glucose value measured belongs to blood glucose target interval, defined as blood glucose level between 100 mg/dl l and 140 mg/dl l.
Time frame: 48 hours
Hypoglycemia
Hypoglycemia is defined as blood glucose level less than 80 mg/dl.
Time frame: 48 hours
Severe hypoglycemia
Severe hypoglycemia is defined as blood glucose level less than 40 mg/dl.
Time frame: 48 hours
Number of patients needing rescue to insulin therapy protocol
Time frame: 48 hours
Number of adverse events occuring in the exenatide group
As the safety of exenatide has never been assessed in the perioperative period in cardiac surgery, all adverse events will be reported, in particular: known adverse events (diarrhea, nausea, vomiting) et severe adverse events (pancreatitis, acute renal failure, death, cardiac arrest).
Time frame: Day 30
Mortality
Time frame: Day 30
Postoperative morbidity
Postoperative morbidity is defined as: * neurological complications: stroke. * renal complication: acute renal failure requiring dialysis. * cardiac complication: cardiogenic shock, arrhythmia, myocardial infarct. * vasopressive drug support in postoperative intensive care unit. * length of postoperative mechanical ventilation. * infectious complication: deep sternal infection.
Time frame: Day 30
The mean (GluAve) and standard deviation (GluSD) of blood glucose
Time frame: 48 hours
The coefficient of variability (GluCV) of blood glucose level
GluCV = GluSD\*100/GluAve
Time frame: 48 hours
Mean number of blood glucose measured
Time frame: 48 hours
Mean difference between each blood glucose measurement and 120 mg/dl
Time frame: 48 hours
Perioperative cardiac mortality
Time frame: Day 30
Perioperative non cardiac mortality
Time frame: Day 30
Length of stay in intensive care unit
Time frame: Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.