About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
IBPS-Guided Ultrafiltration
Other interventionEach 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.
Treatment groups
Trial outcomes
Primary outcomes
Ambulatory Systolic Blood Pressure
Will compare between-group difference in change in ambulatory systolic blood pressure from baseline to 4-month follow up
Secondary outcomes
Extracellular Volume
Will compare the between-group difference in change in post-dialysis extracellular water/body weight measured with multifrequency bioimpedance spectroscopy.
Total Peripheral Resistance Index
Will compare the between-group difference in change in post-dialysis total peripheral resistance index measured with a non-invasive cardiac output monitor.
Intradialytic Hypotension
The investigators will compare the between-group difference in the occurrence of intradialytic systolic blood pressure nadir less than 90 and 95 mmHg.
Association Between intradialytic blood pressure slope with systolic and diastolic dysfunction
The investigators will analyze the correlation between intradialytic blood pressure slopes with both ejection fraction and mitral inflow/mitral annuls velocities measured with transthoracic echocardiograms
Sponsors and contacts
Click on the lead sponsor to view all of their trials.