End Stage Chronic Renal FailureFILTRATENCT07705269
The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion
A study testing High-rate ultrafiltration and Standard fluid removal in people with End Stage Chronic Renal Failure and Congestive Heart Failure (CHF), run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Chronic Renal Failure, Congestive Heart Failure (CHF), Intravascular Congestion
- What is being tested?
- High-rate ultrafiltration and Standard fluid removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jun 2026to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario "Dr. José E. González"
Monterrey, Nuevo León, 64460
Edgar Adrián Montemayor, Nephrology Fellow, +52 8180911271, edgar.montemayorga@uanl.edu.mx
About this study
Official title: 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.
Read more
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
- Being tested
- High-rate ultrafiltration, Standard fluid removal
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-rate ultrafiltrationProcedure or surgery
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.
Standard fluid removalProcedure or surgery
Receives a standard fluid removal rate of 10 mL/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Standar Group | Active comparator | Receives a standard fluid removal rate of 10 mL/kg/h. Receives: 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). Receives: Procedure: High-rate ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: From the date of randomization until hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start4 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Edgar Adrián Montemayor Garza, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705269
- Sponsor's protocol ID
- NF26-00006
- Acronym
- FILTRATE
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the publication