Intravenous Exenatide (Byetta) During Surgery
Status: | Completed |
---|---|
Conditions: | Other Indications, Endocrine, Diabetes |
Therapuetic Areas: | Endocrinology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/29/2017 |
Start Date: | March 2009 |
End Date: | April 2016 |
Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial
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.
normal blood glucose levels and preventing low blood glucose levels during surgery.
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
We found this trial at
1
site
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials