Reduction of occurence of Acute Kidney Injury through administration of angiotensin-II

Phase 1

• Conditions: Cardiac surgical patients at high risk for AKI; MedDRA version: 21.1Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: LLTClassification code 10080266Term: Stage 1 acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: LLTClassification code 10080269Term: Stage 2 acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: LLTClassification code 10080271Term: Stage 3 acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-003088-87-DE
• Lead Sponsor: Westfälische Wilhelms-Universität Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.Adult patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB),
2.18 years of age or older,
3.cardiac index > 2.1 l/min per square meter,
4.Written informed consent.
Registered patients will be randomized only if
1.?-renin (difference between post- and pre-operation) = 3.7 µU/ml 4h after CPB.
2.postoperative hypotension requiring vasopressors

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1.Preexisting AKI (stage 1 and higher)
2.Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
3.Pregnant women, breastfeeding women and women of childbearing potential
4.Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
5.Chronic kidney disease with eGFR < 20 ml/min/1.73m2
6.Dialysis dependent CKD
7.Prior kidney transplant within the last 12 months
8.Emergency surgery in the context of an acute coronary syndrome
9.Hypersensitivity to the active substance, or to any of the excipients of the study medication
10.Bronchospasm
11.Liver failure
12.Mesenteric ischemia
13.Participation in another intervention trial in the past 3 months
14.Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
15.Persons held in an institution by legal or official order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified