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

Launched by UNIVERSITÄT MÜNSTER · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called angiotensin II can help prevent kidney problems in patients undergoing cardiac surgery, specifically those at higher risk for acute kidney injury (AKI). The study will compare the effects of angiotensin II to a commonly used medication called norepinephrine. While previous studies suggest that angiotensin II may be beneficial, we currently lack sufficient human data to confirm its effectiveness in this situation, so this trial aims to fill that gap.

To participate in this trial, you need to be an adult aged 18 or older who is having specific types of cardiac surgery, such as coronary artery bypass or valve surgery, and be at risk for AKI based on certain health criteria. Participants will be closely monitored during the study to see how well angiotensin II works compared to norepinephrine. It's important to note that there are some exclusions, like having major aortic surgery or being on dialysis. If you're interested, the trial has not yet started recruiting participants, but it could be an important step in improving care for patients undergoing heart surgery.

Gender

ALL

Eligibility criteria

• 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