The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion

NCT07705269 | Recruiting

• 1 other identifier: NF26-00006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

End Stage Chronic Renal Failure; Congestive Heart Failure (CHF); Intravascular Congestion; Fluid Overload

Outcome Measures

Primary Outcomes (3)

• Safety (Incidence of Intradialytic Hypotension - IDH)

  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.

  During the interventional hemodialysis session.

• Ultrasound Efficacy

  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.

  Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.

• Clinical Respiratory Efficacy

  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).

  The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Standar Group

ACTIVE COMPARATOR

Receives a standard fluid removal rate of 10 mL/kg/h.

Procedure: Standard fluid removal

High-Rate Group

EXPERIMENTAL

Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety up to 15 mL/kg/h).

Procedure: High-rate ultrafiltration

Interventions

High-rate ultrafiltration PROCEDURE

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 formally structured in previous clinical trials.

High-Rate Group

Standard fluid removal PROCEDURE

Receives a standard fluid removal rate of 10 mL/kg/h.

Standar Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator

Study Sites (1)

Hospital Universitario "Dr. José E. González"

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Failure; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Central Study Contacts

Edgar Adrián Montemayor, Nephrology Fellow

CONTACT

+52 8180911271; edgar.montemayorga@uanl.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Fellow

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ME (1)