The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of \<140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.
Anti-hypertensive medications will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. Adjustment of currently prescribed anti-hypertensive medications will be prioritized before starting new medications. Only standard anti-hypertensive medications will be used, such as RAAS inhibitors, beta-blockers, calcium channel blockers and diuretics.
University of California San Francisco
San Francisco, California, United States
University of Washington
Seattle, Washington, United States
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of IDH
Time frame: 10 months
Fatigue by SONG-HD Score
Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on patient reported fatigue, as ascertained by the SONG-HD Fatigue Score (PMID: 33093215)
Time frame: 10 months
Cramping
Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on frequency of cramping
Time frame: 10 months
Rates of hospitalizations for cardiovascular events and volume overload
Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of hospitalizations for cardiovascular events and volume overload
Time frame: 10 months
Correlation between pre-dialysis and home SBP
Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies
Time frame: 10 months
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