Reducing Acute Kidney Injury Occurence by Administering Angiotensin II

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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) after cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Westfälische Wilhelms-Universität Münster
• Collaborator: German Research Foundation
• Treatments: Angiotensin II; Angiotensinogen; Giapreza

Criteria

Inclusion Criteria:

• 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 µU/ml 4 h after CPB

• Postoperative hypotension requiring vasopressors

Exclusion Criteria:

• 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 eGFR (estimated glomerular filtration rate) < 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