Recruiting

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

ClinicalTrials.gov IDNCT04163614

PhaseNA

Enrollment69

SponsorVA Office of Research and Development

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Other: 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 outcomes

Ambulatory Systolic Blood Pressure (4 months)

Eligibility information

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 locations

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas 75216-7167 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.