Actively Recruiting
A Prospective Angiotensin II Versus Noradrenaline Trial for Hypotension Management to Reduce Cardiac-surgery Associated Acute Kidney Injury (PAN-AKI)
Led by Universität Münster · Updated on 2025-07-18
1022
Participants Needed
4
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
Universität Münster
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of angiotensin II compared to norepinephrine as a primary vasopressor in patients undergoing cardiac surgery to see if angiotensin II can reduce the occurrence of moderate to severe acute kidney injury (AKI). AKI is common after cardiac surgery and is linked to increased complications and mortality. Current treatments like norepinephrine have side effects and may become less effective in vasoplegic shock, a condition often seen after such surgeries. Participants will receive either angiotensin II or norepinephrine through intravenous infusion via a central line, with doses adjusted frequently to maintain a target mean arterial pressure above 65 mmHg. The study includes patients undergoing cardiac surgery with cardiopulmonary bypass and will compare these two vasopressors in this setting. The trial includes a randomized, quadruple-masked design to assess the impact of angiotensin II as a primary vasopressor. During the study, participants will be closely monitored for kidney function and other health outcomes. Researchers will measure the rate of moderate to severe AKI or death within 72 hours after surgery as the main outcome. Additional assessments include kidney events up to 90 days and chronic kidney injury progression up to 120 days post-surgery. The study includes detailed monitoring of vital signs, laboratory tests, and safety throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing cardiac surgery with cardiopulmonary bypass, including coronary artery bypass grafting (CABG), valve surgery, or combined CABG/valve surgery
- Elevated risk of acute kidney injury (AKI) with a risk score of 1.5 or higher based on hemoglobin, creatinine, age, heart classification, or body mass index
- Adults aged 18 years or older
- Able and willing to provide written informed consent
You will not qualify if you...
- Major aortic surgery such as aortic arch replacement, transplant surgery, pulmonary thrombendarterectomy, or ventricular assist device placement
- Receiving inotropic or vasopressor support before surgery
- Dialysis dependent
- Acute kidney injury within the last 30 days
- Chronic kidney injury with estimated glomerular filtration rate (eGFR) below 20 ml/min/1.73m2
- Significant uncontrolled hypertension with systolic blood pressure persistently above 180 mmHg
- Significant pulmonary hypertension with right ventricular dysfunction beyond mild severity
- Known allergy to study drugs or excipients
- Pregnancy or breastfeeding (negative pregnancy test required for women of childbearing age)
- Dependency on the investigator or employment by the sponsor or investigator
- Participation in another interventional trial on kidney function within the last three months
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During and immediately after cardiac surgery
Participants receive intravenous infusion of either Angiotensin II or Noradrenaline through a central line to manage hypotension during cardiac surgery with cardiopulmonary bypass. The infusion dose is adjusted frequently based on the patient's condition and target blood pressure.
Continuous monitoring during surgery and infusion
Duration - Up to 120 days after cardiac surgery
Participants are monitored for kidney function and adverse events after surgery to assess the occurrence and severity of acute kidney injury and other outcomes.
Multiple follow-up visits up to 4 months
Trial Site Locations
Total: 4 locations
1
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
Actively Recruiting
2
University Hospital Bonn
Bonn, Germany, 53127
Actively Recruiting
3
University Medical Center Mainz
Mainz, Germany, 55131
Actively Recruiting
4
University Hospital Münster
Münster, Germany, 49149
Actively Recruiting
Research Team
A
Alexander Zarbock, MD
M
Melanie Meersch-Dini, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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