Intravenous Exenatide (Byetta) During Surgery

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this project is to study if intravenous Exenatide is effective at maintaining normal blood glucose levels and preventing low blood glucose levels during surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Age (>18 years)

• Weight of > 50 kg and < 150 kg

• Ability to provide informed consent

• Elective surgery including:

• Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)

• Abdominal aortic aneurysm repair

• Carotid endarterectomy

• Esophagectomy

• Cystectomy

• Nephrectomy

• If female, subject must be non-lactating, and, if of childbearing potential, must have a negative urine pregnancy test within 24 hours prior to receiving study drug

Exclusion Criteria:

• Age (<18 years)

• Inability to provide informed consent

• History or risk of pancreatitis (e.g. ethanol abuse, gall stones)

• Receipt of an investigational drug or device with 30 days prior to surgery

• Use of any concomitant medication listed above on the day of surgery

• Known allergy to Exenatide, fentanyl, midazolam, isoflurane, propofol, heparin or neuromuscular blockers

• Known substance abuse

• Surgical procedure other than:

Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/ replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)

• Abdominal aortic aneurysm repair

• Carotid endarterectomy

• Esophagectomy

• Cystectomy

• Nephrectomy

• Insulin dependent diabetes mellitis

• Anticipated administration of intraoperative steroids

• Major end organ dysfunction, defined as:

• Current intravenous inotropic agents

• Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO)

• Renal

• Preoperative serum Creatinine > 2.0 mg/dL

• Hepatic

• History of abnormal hepatic function in the past

• Hematologic

• Preoperative hematocrit (HCT) < 30%

• Platelet count < 100,000/mm3

• History of bleeding or clotting disorder