Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Münster
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery
hemoglobin < 130g/l = 2
creatinine > 1.1 mg/dl = 2
age > 70 years =1.5
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Angiotensin II
DrugIntravenous 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.
Noradrenalin
DrugIntravenous 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.
Treatment groups
1,022 Participants
are divided into 2 treatment groupsGroup A: Angiotensin IIExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after end of cardiac surgery.
Time frame
72 hours after end of surgerySecondary outcomes
1
Major Adverse Kidney Events (MAKE90)
1\. MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90)
Time frame
90 after cardiac surgery2
Severity of Acute Kidney Injury
Number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)
Time frame
72 hours after cardiac surgery3
Development or progression of chronic kidney injury
Development or progression of chronic kidney disease based on albuminuria, urine creatinine (and the respective ratio) and serum creatinine or death within 120 days
Time frame
90 to 120 days after cardiac surgeryOther outcomes
1
Use of additional open-label vasopressors or inotropes
Time frame
within 72 h after cardiac surgery2
Volume of fluid application within the first 72 hours
Time frame
within 72 h after cardiac surgery3
Volume status
Time frame
within 72 h after cardiac surgery4
Time to death
Time frame
30 days after cardiac surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität Münster
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov