The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-rate ultrafiltration, Standard fluid removal.
- Who it may be relevant to
- Registry conditions: End Stage Chronic Renal Failure, Congestive Heart Failure (CHF), Intravascular Congestion, Fluid Overload. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial
Overview
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).
Interventions
- Procedure 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 - Procedure Standard fluid removal
Receives a standard fluid removal rate of 10 mL/kg/h.
Primary outcome measures
- Safety (Incidence of Intradialytic Hypotension - IDH) [Time frame: During the interventional hemodialysis session.]
- Ultrasound Efficacy [Time frame: Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.]
- Clinical Respiratory Efficacy [Time frame: The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.]
Secondary outcome measures (5)
- Prediction and Tolerance Analysis [Time frame: Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.]
- Hospital Stay and Support [Time frame: From the date of randomization until hospital discharge, assessed up to 30 days.]
- Blood Pressure Control and Volume [Time frame: Prior to the session (Baseline) and within 24 hours post-intervention.]
- Biomedical and Echocardiographic Variables [Time frame: Prior to the session (Baseline) and within 24 hours post-intervention.]
- Subgroup Analysis (Ventricular Function) [Time frame: From the date of randomization until hospital discharge, assessed up to 30 days.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Hospital Universitario "Dr. José E. González" — Monterrey
Identifiers
NCT: NCT07705269 · NF26-00006