Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

NCT04163614 | Recruiting DMC

• 1 other identifier: NEPH-020-19S
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ambulatory Systolic Blood Pressure

  Will compare between-group difference in change in ambulatory systolic blood pressure from baseline to 4-month follow up

  4 months

Secondary Outcomes (4)

• Extracellular Volume

  4 months

• Total Peripheral Resistance Index

  4 months

• Intradialytic Hypotension

  4 months

• Association Between intradialytic blood pressure slope with systolic and diastolic dysfunction

  3 days

Study Arms (2)

Control

NO INTERVENTION

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.

IBPS (Intradialytic Blood Pressure Slope) Arm

EXPERIMENTAL

IBPS participants will have their target weight adjusted each month by the study investigator based on recent assessment of intradialytic blood pressure slopes.

Other: IBPS-Guided Ultrafiltration

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.

IBPS (Intradialytic Blood Pressure Slope) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Dallas, Texas, 75216-7167, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Noel Van Buren, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter N Van Buren, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Active Control Participants will be managed in entirety by their treating nephrologists The intradialytic blood pressure slope (IBPS) group will have their target weight adjusted each month by study investigator based on recent intradialytic blood pressure slopes

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: February 10, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)