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Evaluating the superiority of VAsopressin versus NOradrenaline in the management of the renal risk patient undergoing cardiac surgery with extracorporeal circulation
EU CTIS ID: 2022-500419-38-00
What this study is testing
To compare 2 blood pressure optimization strategies (vasopressin versus norepinephrine) on the occurrence of a composite end point combining renal complications and death at D7 of the onset of vasoplegic syndrome in patients undergoing cardiac surgery with extracorporeal circulation.
- Therapeutic confirmatory (Phase III)
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
- Patient who has given free, written and informed consent
- Patient of legal age
- Patient requiring cardiac surgery: o Scheduled (> 24h) o With extracorporeal circulation (ECC) o Myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a PFO/ASD
- Patient with at least 3 risk factors for acute kidney failure including: age > 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration < 60 ml min-1, LVEF <40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery > 100 min, albuminuria
- Negative pregnancy test for women of childbearing age
You likely can't join if
- Patient not affiliated to national health insurance or not beneficiary of a social security system
- Patient on ECMO/ECLS
- Patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage)
- Patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of REVERPLEG®
- Patient subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
See the full eligibility criteria
- Patient who has given free, written and informed consent
- Patient of legal age
- Patient requiring cardiac surgery: o Scheduled (> 24h) o With extracorporeal circulation (ECC) o Myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a PFO/ASD
- Patient with at least 3 risk factors for acute kidney failure including: age > 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration < 60 ml min-1, LVEF <40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery > 100 min, albuminuria
- Negative pregnancy test for women of childbearing age
- Patient not affiliated to national health insurance or not beneficiary of a social security system
- Patient on ECMO/ECLS
- Patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage)
- Patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of REVERPLEG®
- Patient subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
- Patients of legal age who are incapable or unable to express their consent
- Patients who have already been included in this study
- Patients requiring emergency surgery (less than 24 hours)
- Patient with chronic kidney failure on dialysis
- Patient with a cardiac transplant
- Patient on left-sided monoventricular assistance
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, 18-64 years, 65+ 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.