drugset / Trial / NCT01969149

Exenatide for Stress Hyperglycemia

NCT01969149

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-01
Primary completion
2015-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 0.025 ug Intravenous
Comparator Insulin Protein / enzyme biologic Intravenous

Indications