Natriuresis-guided Depletion After Cardiac Surgery (NCT07077772) | Clinical Trial Compass
RecruitingNot Applicable
Natriuresis-guided Depletion After Cardiac Surgery
France102 participantsStarted 2025-06-25
Plain-language summary
Fluid overload (FO) is a common complication after cardiac surgery, associated with increased morbidity and mortality. Loop diuretics, especially furosemide, are routinely used to manage FO, but their use is often empirical. Recent data suggest that natriuresis-guided furosemide titration using point-of-care urinary sodium sensors (LAQUAtwin NA-11, Horiba) may improve the efficiency and safety of fluid removal, but no randomized trial has yet evaluated this approach in postoperative cardiac surgery patients
Our goal is to assess the clinical impact, safety, and feasibility of a natriuresis-guided furosemide protocol after cardiac surgery requiring cardiopulmonary bypass.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient (age \> 18 years)
* Scheduled for cardiac surgery, including mitral valve repair or replacement, aortic valve replacement, coronary artery bypass grafting (CABG), ascending aortic repair, or combined procedures
* Undergoing surgery with cardiopulmonary bypass (CPB)
* Eligible to receive intravenous furosemide for fluid overload within 48 hours following surgery, as prescribed by the referring physician
* Written and oral informed consent obtained
* Covered by the French national health insurance (Sécurité Sociale)
Exclusion Criteria:
* Aortic arch repair requiring deep hypothermic circulatory arrest
* Active endocarditis
* Hemodynamic instability requiring vasopressor or inotropic support (norepinephrine, dobutamine, epinephrine, or vasopressin)
* Failure to wean from CPB requiring mechanical circulatory support
* Chronic kidney disease with an estimated glomerular filtration rate (eGFR) \< 60 mL/min
* Chronic use of loop diuretics
* Known allergy to furosemide
* Active postoperative bleeding and/or reoperation for bleeding
* Participation in another interventional study that may affect the primary outcome measure
* Patient deprived of liberty by administrative or judicial decision, or placed under legal protection (guardianship or curatorship)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total urine output (mL) at 48 hours after randomization.