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New treatment option for Cardiac Surgery
Official title Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
ClinicalTrials.gov ID: NCT06615102
What this study is testing
What is Angiotensin II?
Angiotensin II is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiac surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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:
- hemoglobin \< 130g/l = 2
- creatinine \> 1.1 mg/dl = 2
- age \> 70 years =1.5
You likely can't join 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)
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:
- 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
- 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 treatment trial within the last three months that investigates kidney function
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Bonn, Germany
- Mainz, Germany
- Münster, Germany
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Bonn, Germany; Mainz, Germany; Münster, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.