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Reduction of occurence of Acute Kidney Injury through administration of angiotensin II versus Noradrenaline
EU CTIS ID: 2024-517771-21-00
What this study is testing
To investigate the effect of angiotensin II as primary vasopressor on the occurence of moderate or severe acute kidney injury within 72 hours after cardiac surgery
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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: a. hemoglobin < 130g/l = 2 b. creatinine > 1.1 mg/dl = 2 c. age > 70 years =1.5 d. NYHA 4 =1.5 e. BMI > 30 =1.5
- Adult ≥ 18 years
- Written informed consent
You likely can't join if
- Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
- 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
- Already receiving inotropic/vasopressor support before surgery
- Dialysis dependent
- Pre-existing AKI within the last 30 days
See the full eligibility criteria
- 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: a. hemoglobin < 130g/l = 2 b. creatinine > 1.1 mg/dl = 2 c. age > 70 years =1.5 d. NYHA 4 =1.5 e. BMI > 30 =1.5
- Adult ≥ 18 years
- Written informed consent
- Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
- 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
- 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 of angiotensin II and norepinephrine (e.g. sodium metabisulfite, sulfite, chlorobutanol hemihydrate and sodium chloride and water)
- Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.