Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT04163614

Conditions

End Stage Renal Disease

Hypertension

Extracellular Volume Overload

Intradialytic Hypotension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IBPS-Guided Ultrafiltration

Study Details

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.

Conditions

End Stage Renal Disease

Hypertension

Extracellular Volume Overload

Intradialytic Hypotension

Study ID

NCT04163614

Start date

Feb 10, 2021

Status verified date

Jul, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

IBPS-Guided Ultrafiltration

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.

Primary outcome measure

  • Ambulatory Systolic Blood Pressure [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Peter N Van Buren, MD

(214) 857-2214peter.vanburen@va.gov

Locations

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Peter N Van Buren, MD

(214) 857-2214peter.vanburen@va.gov

Principal Investigator:

Peter Noel Van Buren, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • End Stage Renal Disease
  • Hypertension
  • Extracellular Volume
  • Intradialytic Hypotension
  • Bioimpedance Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-20.