Clinical trial

Biomarker-guided Implementation of Angiotensin-II (AT-II) to Reduce the Occurrence of Kidney Damage After Cardiac Surgery

NCT05199493

Name

WWU20_0016

Description

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.

Trial arms

Trial start

2021-12-27

Estimated PCD

2022-12-19

Trial end

2023-03-19

Status

Completed

Phase

Early phase I

Treatment

Angiotensin II

Patients with Delta-renin \>= 3.7 micro-unit/mL are at high risk for AKI. Patients who have a high delta-renin and a postoperative hypotension requiring vasopressors ad will be randomized. After randomization patients will receive intravenous infusion with the investigational drug.

Arms:

Angiotensin II

Control

Arms:

Control

Size

Primary endpoint

• kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization

12 hours after start of intervention

Eligibility 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 micro Unit/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 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

Updated at

2023-03-24

1 organization

1 product

1 drug

3 indications

Organization

Product

Indication

Indication

Indication

Drug