Urine-sodium–guided fluid removal after heart surgery
Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07077772 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Christophe Beyls, MD, PhD
- Email: beyls.christophe@chu-amiens.fr
- Phone: +33322087866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.