Natriuresis-guided Depletion After Cardiac Surgery

Официальное название

Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Total urine output (mL) at 48 hours after randomization. [Срок оценки: 48 hours after randomization]

Вторичные конечные точки (9)

• Urine output at 24 hours [Срок оценки: 24 hours after randomization]
• Natriuresis at 24 hours [Срок оценки: 24 hours after randomization]
• Natriuresis at 48 hours [Срок оценки: 48 hours after randomization]
• VExUS score at 48 hours [Срок оценки: 48 hours after randomization]
• Total loop diuretics [Срок оценки: During the study period (48 hours)]
• Cumulative Fluid balance [Срок оценки: At inclusion and 48 hours after randomization]
• Number of Participants with Postoperative Complications by Day 30 [Срок оценки: Day 30 after randomization]
• Number of Participants with Contraindications to Furosemide Administration [Срок оценки: During the study period (48 hours after randomization)]
• Number of Corrective Measures Implemented Prior to Furosemide Administration [Срок оценки: Within 48 hours after randomization]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Amiens Picardie — Amiens

Публикации

• 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

Идентификаторы

NCT: NCT07077772 · PI2025_843_0080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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