Urine-sodium–guided fluid removal after heart surgery
Official title: Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
Run by Centre Hospitalier Universitaire, Amiens · NCT07077772 · Data updated 2026-11-12
This trial will test whether using bedside urine sodium measurements to guide IV furosemide dosing helps adults who develop fluid overload after heart surgery get rid of excess fluid more safely and efficiently.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07077772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) undergoing cardiac surgery with cardiopulmonary bypass who may require IV furosemide within 48 hours after surgery and who can provide informed consent and are covered by French national health insurance are eligible.
✕Probably not a fit
Patients with hemodynamic instability requiring vasopressors or mechanical circulatory support, chronic kidney disease with eGFR <60 mL/min, chronic loop diuretic use, deep hypothermic circulatory arrest, active endocarditis, or a known allergy to furosemide are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults having cardiac surgery with cardiopulmonary bypass who develop postoperative fluid overload are assigned to receive intravenous furosemide titrated either by point-of-care urine sodium measurements (using a LAQUAtwin NA-11 sensor) or by standard clinical examination and urine output. The natriuresis-guided arm uses serial urinary sodium to adjust dosing aimed at improving sodium and fluid removal, while the control arm follows routine clinical assessment. Outcomes include clinical effectiveness (decongestion and organ function), safety signals such as changes in renal function, and feasibility of bedside sodium monitoring in the postoperative setting. The trial seeks to determine whether urine-sodium guidance can make diuretic therapy more targeted and reproducible after cardiac surgery.
Why it matters
Potential benefit: If successful, this approach could enable faster and safer removal of excess fluid after cardiac surgery, potentially reducing complications and shortening hospital stays.
How similar studies have gone: Early pilot and observational studies suggest natriuresis-guided diuretic titration can improve efficiency and safety of fluid removal, but randomized evidence in postoperative cardiac surgery patients is lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
CHU Amiens Picardie
Amiens, France Recruiting
Study contacts
- Study coordinator: Christophe Beyls, MD, PhD
- Email: beyls.christophe@chu-amiens.fr
- Phone: +33322087866
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.