End Stage Renal Disease on Dialysis
Conditions
Keywords
Blood pressure, dialysis
Brief 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.
Detailed description
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.
Interventions
OTHERDry weight target adjustment
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.
Sponsors
University of Washington
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis | 10 months | Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of IDH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue by SONG-HD Score | 10 months | 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) |
| Cramping | 10 months | Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on frequency of cramping |
| Rates of hospitalizations for cardiovascular events and volume overload | 10 months | Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of hospitalizations for cardiovascular events and volume overload |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNisha Bansal, MD
University of Washington
PRINCIPAL_INVESTIGATORChi-yuan Hsu, MD
University of California, San Francisco
Outcome results
None listed