FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Safety (Incidence of Intradialytic Hypotension - IDH)
研究概览
简要总结
The purpose of this study is to evaluate whether a personalized, high-rate fluid removal strategy guided by ultrasound is as safe and effective as the standard fluid removal rate for patients with advanced kidney disease who are hospitalized due to severe fluid overload (congestion).
When patients with End-Stage Renal Disease (ESRD) on chronic hemodialysis are admitted to the hospital with excess fluid, doctors often need to remove this fluid quickly to relieve symptoms like severe shortness of breath. However, traditional guidelines recommend conservative fluid removal rates-called ultrafiltration (UF) rates-between 10 and 13 mL/kg/h to prevent sudden drops in blood pressure (intradialytic hypotension). Despite these guidelines, doctors in real-world hospital settings frequently use higher rates to provide urgent relief, though this practice lacks strong scientific backing.
This study utilizes advanced bedside ultrasound protocols (such as lung ultrasound and VExUS) to objectively measure the amount of fluid congestion inside the patient's blood vessels. The researchers hypothesize that patients with high ultrasound markers of congestion can safely tolerate higher fluid removal rates because their blood vessels are overfilled, meaning fluid can be pulled out faster without causing blood pressure drops.
Participants will be randomly assigned to one of two groups during their first in-hospital hemodyalisis session:
- Standard Group: Receives a standard fluid removal rate of 10 mL/kg/h.
- High-Rate Group: Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety ceiling up to 15 mL/kg/h).
The study will compare the two groups over the first 24 hours to monitor blood pressure stability (safety) and check for improvements in ultrasound congestion scores, shortness of breath, and the need for supplemental oxygen (effectiveness).
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
- Single (Participant)
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 over 18 years old with End-Stage Renal Disease on hemodialysis for at least 3 months.
- •Admitted to the hospital requiring mechanical fluid removal for acute fluid overload (first in-hospital session).
- •Clear ultrasound evidence of severe intravascular congestion (such as diffuse B-lines in the lungs or altered VExUS vascular flow patterns).
- •Hemodynamically stable with a baseline blood pressure of at least 120/80 mmHg.
排除标准
- •Baseline low blood pressure (<100/60 mmHg) or active shock (cardiogenic, septic, or distributive).
- •Acute coronary syndrome (heart attack), severe heart valve disease, or severe fluid around the heart.
- •Known chronic lung disease.
- •Pregnancy.
结局指标
主要结局
Safety (Incidence of Intradialytic Hypotension - IDH)
时间窗: During the interventional hemodialysis session.
Frequency of episodes defined as a drop in systolic blood pressure (PAS \> 20 mmHg) or mean arterial pressure (PAM \> 10 mmHg) associated with clinical symptoms requiring medical intervention during the session.
Ultrasound Efficacy
时间窗: Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.
Improvement in intravascular congestion parameters and cardiac filling pressures, evaluated through a reduction of at least 1 grade in the VExUS score, a 30% decrease in the lung B-line count, and improvement in echocardiographic parameters.
Clinical Respiratory Efficacy
时间窗: The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.
Clinical improvement of the patient measured by the mMRC dyspnea scale and the documented change in the use of supplemental oxygen (fraction of inspired oxygen \[FiO\_2\] or flow in liters per minute).
次要结局
- Prediction and Tolerance Analysis(Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.)
- Hospital Stay and Support(From the date of randomization until hospital discharge, assessed up to 30 days.)
- Blood Pressure Control and Volume(Prior to the session (Baseline) and within 24 hours post-intervention.)
- Biomedical and Echocardiographic Variables(Prior to the session (Baseline) and within 24 hours post-intervention.)
- Subgroup Analysis (Ventricular Function)(From the date of randomization until hospital discharge, assessed up to 30 days.)
研究者
Edgar Adrián Montemayor Garza
Nephrology Fellow
Universidad Autonoma de Nuevo Leon