Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients (NCT04163614)
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients
🩺 Plain-English Summary (8th-Grade Level)
Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (11 items).
Location: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas
Age range: 18 Years
🧪 Interventions in This Study
- IBPS-Guided Ultrafiltration (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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:
- HemoDialysis Vintage Less than 2 months
- Pregnancy
- Mean systolic blood pressure nadir \<95 mmHg in 2 weeks screening
- Mean pre- or post-dialysis systolic blood pressure \>180 mmHg
- Mean pre to post-HD decrease in blood pressure \>60 mmHg
- Routine intradialytic clonidine use
- Routine intradialytic midodrine use
- Documented antihypertensive medication non-adherence
- Mean ultrafiltration rate \>13 mL/kg/hr during 2 week screening
- For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 857-2214
Email: peter.vanburen@va.gov
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 Renal Disease
- PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis — Washington D.C., District of Columbia
- An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL — Winnipeg, Manitoba
- The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation — Vancouver, British Columbia
- Light Therapy in End Stage Kidney Disease — Philadelphia, Pennsylvania
- Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis — Boston, Massachusetts
Explore by condition: All End Stage Renal Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.