Blood Pressure Management, End Stage Renal Disease (ESRD), Fluid Accumulation
Conditions
Keywords
ESRD, Volume overload, Fluid accumulation, End stage renal disease, Congestion, Chronic dialysis, Blood Pressure (High), Blood pressure management
Brief summary
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations. This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.
Detailed description
This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of 1. Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks 2. Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.
Interventions
PROCEDUREUltrafiltration
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
Sponsors
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a randomized trial to test the effects of two concentrated ultrafiltration strategies in patients receiving maintenance hemodialysis treatments. We will determine the impact of the ultrafiltration strategies on blood pressure, congestion symptoms, and other key metrics of efficacy and safety
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either: 1. Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered. OR 2. Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score \<75.
Exclusion criteria
* Age \<18 years * Receiving hemodialysis treatments for acute kidney injury * Receiving hemodialysis treatments for less than four weeks * Planned switch to peritoneal or home dialysis within next three months * Current or planned incremental hemodialysis (less than 3 treatments per week) * Current or planned intensive hemodialysis (four or more treatments per week) * Scheduled kidney transplantation * Major cardiovascular or bleeding event within previous 90 days * Receiving chemotherapy or radiation treatment for cancer * History of cirrhosis with ascites * Inability to complete 24-hour ambulatory blood pressure measurement * Wheelchair dependance or other inability to complete six-minute walk test * Pre-dialysis systolic blood pressure \<100 mmHg * Scheduled use of midodrine with hemodialysis treatments * History of non-adherence with dialysis treatments * Pregnancy * Institutionalized * Current or pending enrollment in hospice care * Inappropriate for enrollment based on investigator or nephrologist discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour continuous ambulatory blood pressure | Measurement performed at baseline compared to measurement performed at 24 weeks. | Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm. |
| Symptoms of congestion. | Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks. | Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire. |
Countries
United States
Contacts
CONTACTLuisa Rios-Avila
CONTACTErnest Ayers, MSPH
PRINCIPAL_INVESTIGATORBryan Kestenbaum, MD, MS
University of Washington
Outcome results
None listed