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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01361594
Eligibility Criteria:
Inclusion Criteria:
1. Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
2. Post surgical hyperglycemia (BG \> 140 mg/dl).
3. Patients with and without a history of type 2 diabetes
Exclusion Criteria:
1. Patients requiring combination CABG with additional procedures such aorta replacement.
2. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR \< 30 ml/min) or clinically significant hepatic failure.
3. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
4. Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
5. Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
6. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01361594
Study Brief:
Protocol Section:
NCT01361594