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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT05079269
Eligibility Criteria:
Inclusion Criteria:
1. Scheduled for major non-cardiac surgery
2. Having general anaesthesia
3. Are designated ASA physical status ≥2 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life)
4. Subject to at least one of the following risk factors:
1. Age ≥ 65 years
2. History of peripheral arterial surgery
3. History of coronary artery disease
4. History of stroke or transient ischemic attack
5. Serum creatinine \>175 µmol/L (\>2.0 mg/dl)
6. Diabetes requiring medication
7. Current smoking or 15 pack-year history of smoking tobacco
8. Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay),75 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays;
9. B-type natriuretic protein (BNP) ≥ 80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) ≥ 200 ng/L.76,77
10. History of atrial fibrillation
11. Chronically taking at least one anti-hypertensive medication
Exclusion Criteria:
1. Are scheduled for carotid artery surgery
2. Are scheduled for intracranial surgery
3. Are scheduled for pheochromocytoma surgery
4. Require preoperative intravenous vasoactive medications
5. Active decompensated congestive heart failure (documented EF \< 30%)
6. Chronic Kidney Disease (eGFR\< 30 mL/min)
7. History of organ transplantation
8. Rectal surgical procedures
9. Patients receiving preoperative bowel preparation
10. Severe pulmonary edema
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT05079269
Study Brief:
Protocol Section:
NCT05079269