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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT06615102
Eligibility Criteria:
Inclusion Criteria:
1. Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery
2. Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale:
1. hemoglobin \< 130g/l = 2
2. creatinine \> 1.1 mg/dl = 2
3. age \> 70 years =1.5
4. New York Heart Association Classification (NYHA) 4 =1.5
5. Body Mass Index (BMI) \> 30 =1.5
3. Adult ≥ 18 years
4. Written informed consent
Exclusion Criteria:
1. Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
2. Already receiving inotropic/vasopressor support before surgery
3. Dialysis dependent
4. Pre-existing AKI within the last 30 days
5. Pre-existing chronic kidney injury with an eGFR\<20 ml/min/1.73m2
6. Pre-existing significant hypertension (persistent SBP \> 180mmHg)
7. Significant pulmonary hypertension (ePSAP \> 70mmHg, mPAP \> 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild)
8. Hypersensitivity to the active substance or to any of the excipients
9. Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
10. Persons with any kind of dependency on the investigator or employed by the sponsor/investigator
11. Participation in another interventional trial within the last three months that investigates kidney function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06615102
Study Brief:
Protocol Section:
NCT06615102