Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT00882050
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00882050
Study Brief:
Protocol Section:
NCT00882050