Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05568160
Eligibility Criteria:
Inclusion Criteria:
* Patient who has given free, written and informed consent
* Patient of legal age.
* Negative pregnancy test for women of childbearing age
* Patient requiring cardiac surgery:
* Scheduled (\> 24h)
* With extracorporeal circulation (ECC)
* 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 m², LVEF \<40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery \> 100 min, albuminuria
Exclusion Criteria:
* Patient not affiliated to national health insurance or not beneficiary of a social security system,
* 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,
* 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®.
Secondary exclusion criteria:
* Patient not developing persistent arterial hypotension (vasoplegic syndrome), within 12 hours after completion of surgery, defined as persistent mean arterial pressure (MAP) \<65 mmHg despite correction of preload and inotropism, with a cardiac index \>2.2 l min-1 m-2, and not responding to 30 mg cumulative of ephedrine in bolus
* Patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT05568160
Study Brief:
Protocol Section:
NCT05568160