Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 2
- 主要终点
- Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
研究概览
简要总结
The purpose of this study is to assess the effectiveness of routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation in reducing acute kidney injury (AKI) incidence and duration in trauma patients in a teaching institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Injured patients that are admitted to the trauma ICU
排除标准
- •Incarceration
- •Pregnancy
结局指标
主要结局
Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
时间窗: within 24 hours of ICU admission
Number of Acute Kidney Injury (AKI)-Free Days
时间窗: within 7 days of injury
AKI will be defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria, and all stages will be considered AKI: Stage 1 - Serum Creatinine 1.5-1.9 times baseline or ≥0.3 mg/dL increase Stage 2 - Serum Creatinine 2-2.9 times baseline Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to ≥4 mg/dL or Initiation of renal replacement therapy
次要结局
- Number of Participants With Acute Kidney Injury (AKI)(within the first 7 days of ICU admission)
- Quantity of Fluids Administered(48 hours)
- Quantity of Diuretics Administered(48 hours)
- Time to Lactate Normalization(within the first 7 days of ICU admission)
- Type of Fluids Administered(48 hours)
- Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline(within the first 7 days of ICU admission)
- Number of Participants With Need for Renal Replacement Therapy(within the first 30 days of ICU admission)
- Number of ICU-free Days(within first 30 days after injury)
- Stage of Acute Kidney Injury (AKI)(within the first 7 days of ICU admission)
- Number of Ventilator-free Days(within first 30 days after injury)
- Time to Base Excess Normalization(within the first 7 days of ICU admission)
研究者
Gabrielle Hatton
Research Fellow
The University of Texas Health Science Center, Houston