A Prospective Angiotensin II Versus Noradrenaline Trial for Hypotension Management to Reduce Cardiac-surgery Associated Acute Kidney Injury (PAN-AKI)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
University Hospital Bonn
RECRUITING
Bonn
University Medical Center Mainz
RECRUITING
Mainz
University Hospital Münster
RECRUITING
Münster
Contact Information
Primary
Alexander Zarbock, MD
PAN-AKI@ukmuenster.de
+49-251-8347252
Backup
Melanie Meersch-Dini, MD
PAN-AKI@ukmuenster.de
+49-251-8347255
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2027-04
Participants
Target number of participants: 1022
Treatments
Experimental: Angiotensin II
Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg
Active_comparator: Control
Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg
Related Therapeutic Areas
Sponsors
Collaborators: German Research Foundation
Leads: Universität Münster

This content was sourced from clinicaltrials.gov