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Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II

RecruitingPhase 3Ages 18 Years - anyAllUniversität Münster
NCT06615102 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Angiotensin II
  • Noradrenalin
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Where

4 sites
Deutsches Herzzentrum der Charité
Berlin, Germany
University Hospital Bonn
Bonn, Germany
University Medical Center Mainz
Mainz, Germany
University Hospital Münster
Münster, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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