Dry Weight Reduction Intervention Via Extra Ultrafiltration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrafiltration
Procedure/SurgeryUltrafiltration for 4 or 8 weeks compared to no ultrafiltration.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Ultrafiltration sessions for 4 weeksActive comparator 1 intervention
Group B: Ultrafiltration sessions for 8 weeksActive comparator 1 intervention
Group C: Control arm, no ultrafiltration sessionsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
24-hour continuous ambulatory blood pressure
Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
Time frame
Measurement performed at baseline compared to measurement performed at 24 weeks.2
Symptoms of congestion.
Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
Time frame
Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: