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

NCT06615102 | Recruiting Phase 3 DMC

• 2 other identifiers: UniMS23_0019542931418
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 4

Brief Summary

The study intervention focuses on exploring the use of angiotensin II as a primary vasopressor compared to norepinephrine in cardiac surgery patients to investigate whether angiotensin II can reduce the occurrence of moderate/severe acute kidney injury (AKI). Despite its potential, as suggested by trials involving surgical patients, there is currently no human data confirming its effectiveness in preventing moderate/severe AKI in this context. The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.

Conditions

Cardiac Surgery; Vasoplegia

Keywords

cardiac surgery; acute kidney injury; Angiotensin II

Outcome Measures

Primary Outcomes (1)

• Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after end of cardiac surgery.

  72 hours after end of surgery

Secondary Outcomes (3)

• Major Adverse Kidney Events (MAKE90)

  90 after cardiac surgery

• Severity of Acute Kidney Injury

  72 hours after cardiac surgery

• Development or progression of chronic kidney injury

  90 to 120 days after cardiac surgery

Other Outcomes (25)

• Use of additional open-label vasopressors or inotropes

  within 72 h after cardiac surgery

• Volume of fluid application within the first 72 hours

  within 72 h after cardiac surgery

• Volume status

  within 72 h after cardiac surgery

Study Arms (2)

Angiotensin II

EXPERIMENTAL

Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg

Drug: Angiotensin II

Control

ACTIVE COMPARATOR

Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg

Drug: Noradrenalin

Interventions

Angiotensin II DRUG

Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.

Angiotensin II

Noradrenalin DRUG

Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery
• Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale:
• hemoglobin \< 130g/l = 2
• creatinine \> 1.1 mg/dl = 2
• age \> 70 years =1.5
• New York Heart Association Classification (NYHA) 4 =1.5
• Body Mass Index (BMI) \> 30 =1.5
• Adult ≥ 18 years
• Written informed consent

You may not qualify if:

• Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
• Already receiving inotropic/vasopressor support before surgery
• Dialysis dependent
• Pre-existing AKI within the last 30 days
• Pre-existing chronic kidney injury with an eGFR\<20 ml/min/1.73m2
• Pre-existing significant hypertension (persistent SBP \> 180mmHg)
• Significant pulmonary hypertension (ePSAP \> 70mmHg, mPAP \> 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild)
• Hypersensitivity to the active substance or to any of the excipients
• Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
• Persons with any kind of dependency on the investigator or employed by the sponsor/investigator
• Participation in another interventional trial within the last three months that investigates kidney function

Sponsors & Collaborators

• Universität Münster: lead
• German Research Foundation: collaborator

Study Sites (4)

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

RECRUITING

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

University Medical Center Mainz

Mainz, 55131, Germany

RECRUITING

University Hospital Münster

Münster, 49149, Germany

RECRUITING

MeSH Terms

Conditions

Vasoplegia; Acute Kidney Injury

Interventions

Angiotensin II

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Alexander Zarbock, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

+49-251-8347252; PAN-AKI@ukmuenster.de

Melanie Meersch-Dini, MD

CONTACT

+49-251-8347255; PAN-AKI@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Up to 3 years after original manuscript publication
• Access Criteria: Available to researchers with methodologically sound proposals approved by the principal investigator.

Locations

DE (4)