Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Chi-yuan Hsu, MD
Headshot of Chi-yuan Hsu
Chi-yuan Hsu

Description

Summary

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.

Details

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.

Keywords

End Stage Renal Disease on Dialysis Blood pressure, dialysis Kidney Failure, Chronic Antihypertensive Agents Dry weight target adjustment Anti-hypertensive medications Home Systolic Blood Pressure <140 mmHg Pre-Dialysis Systolic Blood Pressure <140 mmHg Home Systolic Blood Pressure <130 mmHg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Aged 18 years or older
  • Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
  • Greater than 3 months since initiation of dialysis
  • No anticipated change to peritoneal dialysis or kidney transplant within 10 months
  • Life expectancy greater than 10 months
  • Hypertension (defined as mean pre-dialysis SBP > 140 mmHg over prior 2 weeks or taking BP medications)
  • Able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit)
  • No condition that the primary nephrologist or PIs feel precludes participation

You CAN'T join if...

  • Incarcerated or institutionalized (prohibits home blood pressure measurement)
  • Participating in another intervention study that may affect blood pressure
  • Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • University of Washington
    Seattle Washington 98104 United States

Lead Scientist at UCSF

  • Chi-yuan Hsu, MD
    Professor, Medicine. Authored (or co-authored) 270 research publications. Research interests: acute · chronic and end-stage renal disease · hypertension.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT05159999
Study Type
Interventional
Last Updated