The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion (FILTRATE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Fluid Overload; Congestive Heart Failure (CHF); End Stage Chronic Renal Failure; Intravascular Congestion
• Intervention / Treatment: Procedure: Standard fluid removal; Procedure: High-rate ultrafiltration

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edgar Adrián Montemayor, Nephrology Fellow; Phone Number: +52 8180911271; Email: edgar.montemayorga@uanl.edu.mx

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Recruiting
      • Hospital Universitario "Dr. José E. González"
      • Contact: Edgar Adrián Montemayor, Nephrology Fellow; Phone Number: +52 8180911271; Email: edgar.montemayorga@uanl.edu.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standar Group; Receives a standard fluid removal rate of 10 mL/kg/h.	Procedure: Standard fluid removal; Receives a standard fluid removal rate of 10 mL/kg/h.
Experimental: High-Rate Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction and Tolerance Analysis	Determining if high baseline VExUS scores and elevated cardiac filling pressures can predict which patients will successfully tolerate the high ultrafiltration rate (>13 mL/kg/h), aiming to establish specific cutoff values using ROC curves.	Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.
Hospital Stay and Support	Measuring and comparing the difference between both groups in total days of hospital stay and days of supplemental oxygen requirement.	From the date of randomization until hospital discharge, assessed up to 30 days.
Blood Pressure Control and Volume	Correlating the total volume of ultrafiltration programmed versus the volume achieved at the end of the session, and comparing the impact on blood pressure control (pre-dialysis vs. post-dialysis at 24 hours).	Prior to the session (Baseline) and within 24 hours post-intervention.
Biomedical and Echocardiographic Variables	Analyzing the quantitative change in natriuretic peptide (NT-proBNP) levels before and within 24 hours after the session.	Prior to the session (Baseline) and within 24 hours post-intervention.
Subgroup Analysis (Ventricular Function)	Exploring whether Left Ventricular Ejection Fraction (LVEF), natriuretic peptides, or pre-dialysis blood pressure modify or influence the clinical response to the specific ultrafiltration profile used	From the date of randomization until hospital discharge, assessed up to 30 days.

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Collaborators: Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Failure; Renal Insufficiency, Chronic; Edema
• Other Study ID Numbers: NF26-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data underlying the results reported in the publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No