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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natriuresis-Guided Arm | Experimental | Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device. |
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| Control | Active Comparator | Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urine output at 24 hours | 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. | 24 hours after randomization |
| Natriuresis at 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Beyls, MD, PhD | Contact | +33322087866 | beyls.christophe@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | 80000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057198 | Derived | 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. |
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Individual participant data (IPD) will not be publicly shared. However, reasonable requests from qualified researchers will be considered after publication of the main results, subject to data use agreements and ethical approval
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| ID | Term |
|---|---|
| D006940 | Hyperemia |
| D007010 | Hyponatremia |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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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:
The study protocol will be implemented over a 48-hour timeframe starting from patient inclusion.
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| 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. |
|
Total natriuresis is measured at 24 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory. |
| 24 hours after randomization |
| Natriuresis at 48 hours | Total natriuresis is measured at 48 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory. | 48 hours after randomization |
| VExUS score at 48 hours | The VExUS score is an echocardiographic score (ranging from 0 to 3) used to assess venous congestion at the cardiac, renal, and hepatic levels. This score will be measured after randomization and at 48 hours after randomization. Grade 0: IVC <2cm = No Congestion Grade 1: IVC >2cm with any combo of Normal or Mildly Abnormal Patterns = Mild Congestion Grade 2: IVC >2cm and one severely Abnormal Pattern = Moderate Congestion Grade 3: IVC >2cm and >2 Severely Abnormal Patterns = Severe Congestion | 48 hours after randomization |
| Total loop diuretics | Total dose of loop diuretics administered during the study period (mg) | During the study period (48 hours) |
| Cumulative Fluid balance | Fluid balance corresponds to the difference between administered fluids (intravenous infusions, blood products, enteral nutrition) and fluid losses (urine output, blood loss, digestive losses, drain output). It is calculated using the DianeRéa software (Bowmedical, version 4.8.11.22887), taking into account all fluid inputs (administered fluids, medications, nutrition) and all fluid outputs (urine, drains, perspiration) over the period from inclusion to 48 hours after randomization | At inclusion and 48 hours after randomization |
| Number of Participants with Postoperative Complications by Day 30 | Composite outcome measuring the number of participants who experience at least one of the following postoperative complications within 30 days of surgery: Cardiovascular:
Respiratory:
Renal: - Acute kidney injury (AKI), defined by a postoperative increase in serum creatinine of at least 50% and/or ≥ 26.5 µmol/L from baseline, and/or urine output < 0.5 mL/kg/h for ≥ 6 hours (KDIGO criteria). Serum creatinine and estimated glomerular filtration rate (eGFR) measured on the day of hospital discharge. Gastrointestinal:
| Day 30 after randomization |
| Number of Participants with Contraindications to Furosemide Administration | Number of participants presenting contraindications prior to furosemide administration, including:
| During the study period (48 hours after randomization) |
| Number of Corrective Measures Implemented Prior to Furosemide Administration | Number of participants for whom corrective actions (e.g., potassium supplementation, fluid resuscitation) were implemented to allow safe administration of furosemide. | Within 48 hours after randomization |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |