Exenatide for Stress Hyperglycemia

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: AstraZeneca; Eli Lilly and Company
• Treatments: Exenatide; Incretins; Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Age over 18.

• Patient consent.

• Non insulin requiring type 2 diabetic patients.

• Non diabetic patients.

• Planned coronary artery bypass graft (CABG) surgery.

• ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion Criteria:

• Pregnancy and breast feeding.

• Pancreatectomy.

• Acute pancreatitis.

• Chronic pancreatitis.

• Type 1 diabetic patients.

• Insulin requiring type 2 patients.

• HbA1c>8%

• Ketoacidosis.

• Hyperosmolar coma.

• Preoperative blood glucose level above 300 mg/dl [21].

• Insulin or exenatide contraindication.

• History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.

• Emergency surgery.

• Planned non CABG cardiac surgery.