Natriuresis-guided Depletion After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Furosemide intravenous titration based on natriuresis, Furosemide intravenous titration based on clinical examination.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery, Diuresis, Congestion, Venous, Sodium Depletion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
Overview
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.
Interventions
- Drug Furosemide intravenous titration based on natriuresis
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUAtwin NA-11 device. Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking. If natriuresis is \< 70 mmol/L, the furosemide dose will be doubled, with a maximum limit of 200 mg per bolus. If natriuresis is ≥ 70 mmol/L, the current dose will be maintained. Blood electrolyte panels and renal function assessments will be performed twice daily throughout th - Drug Furosemide intravenous titration based on clinical examination
Furosemide IV, 20 mg starting dose, titrated every 6 hours clinical evaluation. Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking. The furosemide dosage will be adjusted based on urine output with a maximum bolus dose of 200 mg. Dose adjustments will be reassessed every 6 hours throughout the study period. Blood electrolyte panels and renal function assessments will be performed twice daily throughout the protocol. In the event of hemodynamic insta
Primary outcome measures
- Total urine output (mL) at 48 hours after randomization. [Time frame: 48 hours after randomization]
Secondary outcome measures (9)
- Urine output at 24 hours [Time frame: 24 hours after randomization]
- Natriuresis at 24 hours [Time frame: 24 hours after randomization]
- Natriuresis at 48 hours [Time frame: 48 hours after randomization]
- VExUS score at 48 hours [Time frame: 48 hours after randomization]
- Total loop diuretics [Time frame: During the study period (48 hours)]
- Cumulative Fluid balance [Time frame: At inclusion and 48 hours after randomization]
- Number of Participants with Postoperative Complications by Day 30 [Time frame: Day 30 after randomization]
- Number of Participants with Contraindications to Furosemide Administration [Time frame: During the study period (48 hours after randomization)]
- Number of Corrective Measures Implemented Prior to Furosemide Administration [Time frame: Within 48 hours after randomization]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens Picardie — Amiens
Publications
- Beyls C, Mollet N, Gibert L, Huette P, Khamari M, Meynier J, Abou-Arab O, Mahjoub Y. Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study. BMJ Open. 2025 Oct 6;15(10):e108600. doi: 10.1136/bmjopen-2025-108600. PMID 41057198
Identifiers
NCT: NCT07077772 · PI2025_843_0080