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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT05199493
Eligibility Criteria:
Inclusion Criteria:
* Adult patients undergoing cardiac surgery with CPB
* Cardiac index 2.1l/min per square meter
* Written informed consent
* D-renin (difference between post- and preoperative) ≥ 3.7 micro Unit/ml 4 h after CPB
* Postoperative hypotension requiring vasopressors
Exclusion Criteria:
* Preexisting AKI (stage 1 and higher)
* Patients with cardiac assist devices
* Pregnant women, nursing women and women of childbearing potential
* Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
* chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 ml/min
* Dialysis dependent chronic kidney disease
* Prior kidney transplant within the last to 12 months
* Emergency surgery in the context of an acute coronary syndrome
* Hypersensitivity to the active substance, or to any of the excipients of the study medication
* Bronchospasm
* Liver failure
* Mesenteric ischemia
* Participation in another intervention trial in the past 3 months
* Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
* Persons held in an institution by legal or official order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05199493
Study Brief:
Protocol Section:
NCT05199493