Natriuresis-guided Depletion After Cardiac Surgery

NCT07077772 | Recruiting

• 1 other identifier: PI2025_843_0080
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Diuresis; Congestion, Venous; Sodium Depletion; Fluid Over-load

Keywords

natriuresis; fluid overload; cardiac surgery; furosemide; venous congestion; loop diuretics

Outcome Measures

Primary Outcomes (1)

• Total urine output (mL) at 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

  48 hours after randomization

Secondary Outcomes (9)

• Urine output at 24 hours

  24 hours after randomization

• Natriuresis at 24 hours

  24 hours after randomization

• Natriuresis at 48 hours

  48 hours after randomization

• VExUS score at 48 hours

  48 hours after randomization

• Total loop diuretics

  During the study period (48 hours)

Study Arms (2)

Natriuresis-Guided Arm

EXPERIMENTAL

Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device.

Drug: Furosemide intravenous titration based on natriuresis

Control

ACTIVE COMPARATOR

Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation

Drug: Furosemide intravenous titration based on clinical examination

Interventions

Furosemide intravenous titration based on clinical examination DRUG

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 instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.

Control

Furosemide intravenous titration based on natriuresis DRUG

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 the protocol. In the event of hemodynamic instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.

Natriuresis-Guided Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, 80000, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Hyperemia; Hyponatremia; Edema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Beyls, MD, PhD

CONTACT

+33322087866; beyls.christophe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium (experimental) or clinical evaluation (control) The investigators predefined safety criteria to be assessed prior to each furosemide injection in order to monitor potential complications related to its administration, including: * Symptomatic hypotension, defined as a mean arterial pressure \< 65 mmHg requiring fluid resuscitation or vasopressor support; * Hypokalemia, defined as a serum potassium concentration \< 3 mmol/L; * Impaired renal function, defined as a doubling of serum creatinine or a ≥50% decrease in estimated glomerular filtration rate (eGFR) within the first 48 hours. The study protocol will be implemented over a 48-hour timeframe starting from patient inclusion.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)