Intravenous Exenatide (Byetta) During Surgery (NCT00882050) | Clinical Trial Compass
CompletedPhase 1/2
Intravenous Exenatide (Byetta) During Surgery
United States104 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < 126 mg/dL in Surgical Subjects as Compared to Placebo,
Timeframe: Baseline and 90 minutes after starting infusion;