The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion

Universidad Autonoma de Nuevo Leon

Status: Enrolling

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

Treatments: Procedure: Standard fluid removal; Procedure: High-rate ultrafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT07705269

NF26-00006

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Standar Group

Active Comparator group

Description:

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

Treatment:

Procedure: Standard fluid removal

High-Rate Group

Experimental group

Description:

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

Treatment:

Procedure: High-rate ultrafiltration