Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. juli 2026 opdateret af: Edgar Adrián Montemayor Garza, Universidad Autonoma de Nuevo Leon

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Rekruttering
        • Hospital Universitario "Dr. José E. González"
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prediction and Tolerance Analysis
Tidsramme: Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.
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
Tidsramme: From the date of randomization until hospital discharge, assessed up to 30 days.
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
Tidsramme: Prior to the session (Baseline) and within 24 hours post-intervention.
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
Tidsramme: Prior to the session (Baseline) and within 24 hours post-intervention.
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)
Tidsramme: From the date of randomization until hospital discharge, assessed up to 30 days.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de Nuevo Leon

Samarbejdspartnere

Hospital Universitario Dr. Jose E. Gonzalez

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NF26-00006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual participant data underlying the results reported in the publication

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Væskeoverbelastning

Kliniske forsøg med Standard fluid removal

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kenya

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner