Angiotensin II: 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.
Noradrenalin: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after end of cardiac surgery. — 72 hours after end of surgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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