Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Total urine output (mL) at 48 hours after randomization.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Natriuresis-Guided Arm
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device.
干预措施: Furosemide intravenous titration based on natriuresis (Drug)
Control
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation
干预措施: Furosemide intravenous titration based on clinical examination (Drug)
结局指标
主要结局
Total urine output (mL) at 48 hours after randomization.
时间窗: 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
次要结局
- 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)
研究者
Beyls
Principal Investigator
Centre Hospitalier Universitaire, Amiens