Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Total urine output (mL) at 48 hours after randomization.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Natriuresis-Guided Arm
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device.
Intervention: Furosemide intravenous titration based on natriuresis (Drug)
Control
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation
Intervention: Furosemide intravenous titration based on clinical examination (Drug)
Outcomes
Primary Outcomes
Total urine output (mL) at 48 hours after randomization.
Time Frame: 48 hours after randomization
All patients were equipped with urinary catheters, allowing for continuous urine collection. Urine output was measured every 2 hours, and the recorded volumes were entered into a monitoring software to ensure accurate follow-up
Secondary Outcomes
- Natriuresis at 48 hours(48 hours after randomization)
- Urine output at 24 hours(24 hours after randomization)
- Natriuresis at 24 hours(24 hours after randomization)
- VExUS score at 48 hours(48 hours after randomization)
- Total loop diuretics(During the study period (48 hours))
- Cumulative Fluid balance(At inclusion and 48 hours after randomization)
- Number of Participants with Postoperative Complications by Day 30(Day 30 after randomization)
- Number of Participants with Contraindications to Furosemide Administration(During the study period (48 hours after randomization))
- Number of Corrective Measures Implemented Prior to Furosemide Administration(Within 48 hours after randomization)
Investigators
Beyls
Principal Investigator
Centre Hospitalier Universitaire, Amiens