🏛️ Verified NIH Record • Updated 2026-07-12

The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion (NCT07705269)

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

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Universidad Autonoma de Nuevo Leon

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).

Location: Hospital Universitario "Dr. José E. González" — Monterrey, Nuevo León

Age range: 18 Years

🧪 Interventions in This Study

  • High-rate ultrafiltration (PROCEDURE)
  • Standard fluid removal (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Hospital Universitario "Dr. José E. González" — Monterrey, Nuevo León

📞 Contact the Study Coordinator

Phone: +52 8180911271

Email: edgar.montemayorga@uanl.edu.mx

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in End Stage Chronic Renal Failure

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗