The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion

Официальное название

FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial

Обзор

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).

Вмешательства

• Процедура High-rate ultrafiltration
  This intervention consists of fluid removal (ultrafiltration) during the first in-hospital hemodialysis session of a patient with advanced Chronic Kidney Disease, utilizing a high rate greater than 13 mL/kg/h (with a strict safety limit established between \>13 and up to 15 mL/kg/h).The differentiating value of this protocol lies in the fact that it challenges traditional medical dogma by combining an aggressive rate with advanced multiparametric ultrasound tools, something that had not been for
• Процедура Standard fluid removal
  Receives a standard fluid removal rate of 10 mL/kg/h.

Первичные конечные точки

• Safety (Incidence of Intradialytic Hypotension - IDH) [Срок оценки: During the interventional hemodialysis session.]
• Ultrasound Efficacy [Срок оценки: Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.]
• Clinical Respiratory Efficacy [Срок оценки: The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.]

Вторичные конечные точки (5)

• Prediction and Tolerance Analysis [Срок оценки: Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.]
• Hospital Stay and Support [Срок оценки: From the date of randomization until hospital discharge, assessed up to 30 days.]
• Blood Pressure Control and Volume [Срок оценки: Prior to the session (Baseline) and within 24 hours post-intervention.]
• Biomedical and Echocardiographic Variables [Срок оценки: Prior to the session (Baseline) and within 24 hours post-intervention.]
• Subgroup Analysis (Ventricular Function) [Срок оценки: From the date of randomization until hospital discharge, assessed up to 30 days.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Hospital Universitario "Dr. José E. González" — Monterrey

Идентификаторы

NCT: NCT07705269 · NF26-00006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗