Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
A Prospective Angiotensin II Versus Noradrenaline Trial for Hypotension Management to Reduce Cardiac-surgery Associated Acute Kidney Injury (PAN-AKI)
Universität Münster
1,022 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria11
- 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
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Interventions
Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.
Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06615102