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Intravenous Exenatide (Byetta) During Surgery - NCT00882050-19104(Clinical Trial 284351)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Euglycemia - Hypoglycemia - Hyperglycemia
Purpose: 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.
Study summary:
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
Study is available at: University of Pennsylvania
Philadelphia, PA 19104
United States

Primary Contact:
Mary S. Hammond, BSN
Email: mary.hammond@uphs.upenn.edu
Phone: 215-662-3772

Secondary Contact:
Mary S. Hammond, BSN
Email: mary.hammond@uphs.upenn.edu
Phone: 215-662-3772
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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