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

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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.


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
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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