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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT06453161
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Cardiac surgery with cardiopulmonary bypass
* Presenting a simplified renal risk score ≥ 2 points defined as follows:
* Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
* Diabetes requiring treatment: 1 point
* LVEF ≤ 40%: 1 point
* Previous cardiac surgery: 1 point
* Pre-operative intra-aortic counter pulsation: 1 point
* Non elective surgery: 1 point
* Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point
Exclusion Criteria:
* Haemodialysis prior to surgery
* Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2.
* Death in the operating theatre
* Opposition of the patient to the use of his/her health data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06453161
Study Brief:
Protocol Section:
NCT06453161