Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
Recruiting now · Phase 3
Conditions studied: Cardiac Surgery, Vasoplegia
In brief
The study intervention focuses on exploring the use of angiotensin II as a primary vasopressor compared to norepinephrine in cardiac surgery patients to investigate whether angiotensin II can reduce the occurrence of moderate/severe acute kidney injury (AKI). Despite its potential, as suggested by trials involving surgical patients, there is currently no human data confirming its effectiveness in preventing moderate/severe AKI in this context. The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.
Key facts
- Study ID
- NCT06615102
- Run by
- Universität Münster
- People needed
- 1022
- Starts
- 2025-03-31
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery
- Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale:
- hemoglobin < 130g/l = 2
- creatinine > 1.1 mg/dl = 2
- age > 70 years =1.5
- New York Heart Association Classification (NYHA) 4 =1.5
- Body Mass Index (BMI) > 30 =1.5
- Adult ≥ 18 years
- Written informed consent
You may not qualify if…
- Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
- Already receiving inotropic/vasopressor support before surgery
- Dialysis dependent
- Pre-existing AKI within the last 30 days
- Pre-existing chronic kidney injury with an eGFR<20 ml/min/1.73m2
- Pre-existing significant hypertension (persistent SBP > 180mmHg)
- Significant pulmonary hypertension (ePSAP > 70mmHg, mPAP > 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild)
- Hypersensitivity to the active substance or to any of the excipients
- Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
- Persons with any kind of dependency on the investigator or employed by the sponsor/investigator
- Participation in another interventional trial within the last three months that investigates kidney function
Where it is running
- Deutsches Herzzentrum der Charité — Berlin, Germany (enrolling)
- University Hospital Bonn — Bonn, Germany (enrolling)
- University Medical Center Mainz — Mainz, Germany (enrolling)
- University Hospital Münster — Münster, Germany (enrolling)
Full record on ClinicalTrials.gov
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