RecruitingNot ApplicableNCT04163614

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients

Sponsor

VA Office of Research and Development

Enrollment

69 participants

Start Date

Feb 10, 2021

Study Type

INTERVENTIONAL

Conditions

Hypertension End Stage Renal Disease Extracellular Volume Overload Intradialytic Hypotension

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria10

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)

Interventions

OTHERIBPS-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.