Status:
COMPLETED
Reducing Acute Kidney Injury Occurence by Administering Angiotensin II
Lead Sponsor:
Universität Münster
Collaborating Sponsors:
German Research Foundation
Conditions:
Cardiac Surgery
Vasoplegia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate whether adding angiotensin II to the standard of care is superior compared to the standard of care alone with respect to kidney damage (personalized approach) afte...
Detailed Description
Vasoplegic syndrome is a form of distributive shock that is characterized by low arterial pressure with reduced systemic vascular resistance and normal or elevated cardiac output that occurs in 5 to 2...
Eligibility Criteria
Inclusion
- Adult patients undergoing cardiac surgery with CPB
- Cardiac index 2.1l/min per square meter
- Written informed consent
- D-renin (difference between post- and preoperative) ≥ 3.7 micro Unit/ml 4 h after CPB
- Postoperative hypotension requiring vasopressors
Exclusion
- Preexisting AKI (stage 1 and higher)
- Patients with cardiac assist devices
- Pregnant women, nursing women and women of childbearing potential
- Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
- chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 ml/min
- Dialysis dependent chronic kidney disease
- Prior kidney transplant within the last to 12 months
- Emergency surgery in the context of an acute coronary syndrome
- Hypersensitivity to the active substance, or to any of the excipients of the study medication
- Bronchospasm
- Liver failure
- Mesenteric ischemia
- Participation in another intervention trial in the past 3 months
- Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
- Persons held in an institution by legal or official order
Key Trial Info
Start Date :
December 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05199493
Start Date
December 27 2021
End Date
March 19 2023
Last Update
March 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Muenster
Münster, Germany, 48149