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

Launched by UNIVERSITÄT MÜNSTER · Sep 23, 2024

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Trial Information

Current as of March 11, 2025

Not yet recruiting

Keywords

Cardiac Surgery Acute Kidney Injury Angiotensin Ii

ClinConnect Summary

Acute kidney injury (AKI) is defined by changes in serum creatinine and/or urine output, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. In cardiac surgical patients, the AKI rate is up to 30%, with 1-2% of the patients requiring renal replacement therapy (RRT). Cardiac-surgery associated AKI (CSA-AKI) is associated with increased short- and long-term morbidity and mortality as well as increased hospital costs.

Shock after cardiac surgery is also associated with increased mortality. In the context of cardiac surgery with the use of the cardiopulmonary bypass (C...

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

Trial Officials

Alexander Zarbock, MD

Principal Investigator

University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

About Universität Münster

Universität Münster is a leading research institution in Germany, renowned for its commitment to advancing knowledge across various scientific disciplines, including medicine and health sciences. The university actively engages in clinical trials to explore innovative treatments and therapies, fostering collaboration between researchers, healthcare professionals, and industry partners. With a focus on improving patient outcomes and contributing to evidence-based medicine, Universität Münster emphasizes rigorous scientific methodologies and ethical standards in its clinical research endeavors. Its multidisciplinary approach ensures a comprehensive understanding of complex health challenges, positioning the university as a pivotal player in the advancement of medical science.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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