Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Cumulative fluid balance
研究概览
简要总结
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.
The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Group allocation masking to staff performing result analyses
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
- •Patient 18 yo or more, affiliated to a social security system
- •Treated with vasopressors for acute circulatory failure
- •With KDIGO stage 3 acute kidney injury
- •Treated with continuous renal replacement therapy for less than 24 jours
- •Monitored with a calibrated continuous cardiac output device
排除标准
- •Treatment by ECMO (extracorporeal membrane oxygenation)
- •Active hemorrhage necessitating transfusion
- •Maintenance dialysis or renal graft recipient
- •Switch to intermittent hemodialysis is scheduled in the next 72 hours
- •Acute cerebral stroke complicated by coma and under mechanical ventilation
- •Acute fulminant hepatitis
- •Postural maneuver (passive leg raising or Trendelenburg) cannot be performed (amputation, inferior vena cava obstruction)
- •Pregnancy or lactating
- •Withdrawal or limitation of care
- •Moribund patient
- •Patient under protective measures/wardship
- •Inclusion in another trial whose main outcome is cumulative fluid balance, or whose intervention targets hemodynamic physiology, fluid balance or net ultrafiltration.
- •Patient previously enrolled in the same study
结局指标
主要结局
Cumulative fluid balance
时间窗: 72 hours from study inclusion (H72)
The cumulative fluid balance (in ml) will be calculated as the total amount of input received by the patients (including IV fluids and medications, blood products, hydration and nutrition), minus the total output over the same period of time (including urine output, net ultrafiltration, and drains). The cumulative fluid balance at H72 will be compared between study groups in alive patients at H72.
次要结局
- Lactatemia(Every 4 hours from inclusion to 72 hours after inclusion)
- Severity of organ failures using the SOFA score(from inclusion to 72 hours of study inclusion)
- Mean arterial pressure(Every 4 hours from inclusion to 72 hours after inclusion)
- Duration of stay in Intensive Care Unit (ICU)(Day 90 of study inclusion)
- Cardiac index(Every 4 hours from inclusion to 72 hours after inclusion)
- Vasopressor dose administered(Every 4 hours from inclusion to 72 hours after inclusion)
- Hospitalisation duration(Day 90 of study inclusion)
- PaO2/FiO2 ratio(24 hours, 48 hours, and 72 hours from study inclusion)
- Number of hemodynamic episodes with preload dependence status(72 hours from study inclusion)
- Number of Major Adverse Kidney Events (MAKE)(90 days from study inclusion)
- Cumulative net ultrafiltration(24 hours, 72 hours and day 7 from study inclusion)
- Number of respiratory and circulatory failure free days(Day 28 of study inclusion)
- Survival(Day 28 and 90 of study inclusion)
- Number of hemodynamic episodes(72 hours from study inclusion)
- Cumulative fluid balance(24 hours and day 7 from study inclusion)
- Extravascular lung water index(24 hours, 48 hours, and 72 hours from study inclusion)