Status:
COMPLETED
Intravenous Exenatide (Byetta) During Surgery
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Conditions:
Euglycemia
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
This is a single-center, block randomized, double-blind, placebo-controlled, dose-ranging study. Subjects will be randomized in equal proportions to one of three treatment arms: placebo of normal sali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00882050
Start Date
March 1 2009
End Date
April 1 2016
Last Update
January 21 2022
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104