Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT04163614
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Extracellular Volume Overload
  • Hypertension
  • Intradialytic Hypotension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBPS-Guided Ultrafiltration — OTHER
    Each month, the study investigator will review the average intradialytic blood pressure slope from the prior two weeks. A prespecified algorithm will be used to prescribe additional fluid removal/weight reduction based on this slope.

Study Details

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.

Key Dates

Start date
Feb 10, 2021
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Participants in the control group will have their blood pressure, fluid status, as well as all other aspects of clinical care managed in entirety by their treating nephrologists.
  • Experimental: IBPS (Intradialytic Blood Pressure Slope) Arm
    IBPS participants will have their target weight adjusted each month by the study investigator based on recent assessment of intradialytic blood pressure slopes.

Primary Outcome Measure

Ambulatory Systolic Blood Pressure [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Peter N Van Buren, MD
[email protected]
(214) 857-2214
Peter Noel Van Buren, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
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By research site
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX· Dallas, TX

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