The Impact of VeXUS-guided Fluid Management in ICU Populations on Renal Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- In-hospital Mortality
研究概览
简要总结
This study will evaluate the use of the Venous Excess Ultrasound (VExUS) score to guide fluid management in critically ill ICU patients through a prospective, multi-aim design combining observational and randomized components. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.
详细描述
This study will evaluate the use of the Venous Excess Ultrasound (VExUS) score to guide fluid management in critically ill ICU patients through a prospective, multi-aim design combining observational and randomized components. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.
Informed Arm: The treating team receives the patient's VExUS results and management recommendations.
Not-Informed Arm: The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
Each enrolled patient will undergo two VExUS ultrasound assessments:
Timepoint 1 (enrollment): Two scans are performed by separate operators to assess waveform reliability and inter-user reproducibility.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To maintain study integrity and minimize bias, multiple layers of blinding will be employed:
Scanner Blinding: Sonographers performing the VExUS scans are blinded to the patient's randomization status and to all prior scan results. They collect and upload de-identified images labeled only by study ID.
Interpreter Blinding: The attending physician interpreting the scans (the "overreader") is blinded to randomization status during the image interpretation phase. The overreader reviews both scans for quality and assigns a VExUS score (0-3) before randomization status is revealed.
Recruiter/Coordinator Role: The research coordinator (unblinded) maintains the randomization list and is responsible for communicating the overread results to the treating team only for patients in the informed arm.
Primary Team Blinding: For patients in the not-informed arm, the primary clinical team will not receive any VExUS scores or recommendations, and no study-related documentation will be visible in
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
- •Adults (≥18 years old)
- •Admitted to the MICU, MCCU, or CCU within 24 hours of admission
- •Acute kidney injury (AKI) (based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria)
- •Adequate acoustic windows for a complete VExUS scan
排除标准
- •< 18 years old
- •pregnant women
- •End-stage renal disease (ESRD) or prior renal transplant
- •Acute tubular necrosis (ATN) defined by urinalysis (≥2+ protein, ≥2+ blood, ≥1 muddy brown cast, ≥1 RBC cast, or ≥1 dysmorphic RBC)'
- •Prior Whipple procedures
- •currently incarcerated
研究组 & 干预措施
Informed
The treating team receives the patient's VExUS results and management recommendations.
干预措施: Fluid Management (Other)
Non-informed
The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
干预措施: No intervention (Other)
结局指标
主要结局
In-hospital Mortality
时间窗: up to 30 days
In-hospital mortality: Death from any cause before hospital discharge, within the 30-day window.
Renal Replacement Therapy
时间窗: up to 30 days
New receipt of Renal Replacement Therapy (RRT): Receiving dialysis or another form of RRT for the first time.
Persistent Renal Dysfunction
时间窗: up to 30 days
Persistent renal dysfunction: The final serum creatinine value before hospital discharge (within 30 days) is 200% (twice) or more of the patient's baseline creatinine value.
Creatinine Change
时间窗: 48 - 72 hrs
A patient's change in creatinine from enrollment at the 48 - 72 hrs
次要结局
未报告次要终点
研究者
Steven W Fox
Assistant Professor
University of Alabama at Birmingham