Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A diminution of quality of life is often reported by patients after coronary artery bypass graft (CABG) surgery. A part of this diminution could be explain by postoperative left ventricular (LV) dysfunction.

Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. Recent data have suggested that exenatide could improve LV function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. Moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo.

The investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in CABG surgery patients.

• 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.