NCT07705269Recruiting
The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion
FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 4 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT07705269
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 4 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute coronary syndrome (heart attack), severe heart valve disease, or severe fluid around the heart.
- Known chronic lung disease.
Other
- Baseline low blood pressure (\<100/60 mmHg) or active shock (cardiogenic, septic, or distributive).
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.