NCT04163614 Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
| NCT ID | NCT04163614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2021-02-10 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 69 participants in total. It began in 2021-02-10 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Hemodialysis patient * Pre-dialysis systolic blood pressure greater than 140 mmHg averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 mmHg averaged over 2 weeks 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)
Contact & Investigator
Peter Noel Van Buren, MD
PRINCIPAL INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Frequently Asked Questions
Who can join the NCT04163614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04163614 currently recruiting?
Yes, NCT04163614 is actively recruiting participants. Contact the research team at peter.vanburen@va.gov for enrollment information.
Where is the NCT04163614 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04163614 clinical trial?
NCT04163614 is sponsored by VA Office of Research and Development. The principal investigator is Peter Noel Van Buren, MD at VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX. The trial plans to enroll 69 participants.