Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- 5D Elman Itch Scale total score
Study Overview
Brief Summary
This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.
The main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?
Researchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.
Participants will:
- receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months;
- fill in questionnaires about intensity of pruritis and its impact on daily life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
- •Moderate-to-severe pruritis (WI-NRS score ≥ 4);
- •Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
- •Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
- •Signed informed consent.
Exclusion Criteria
- •Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
- •Noncompliance of the patient with the protocol (in the investigator's opinion).
- •Use of haemodiafiltration.
Outcomes
Primary Outcomes
5D Elman Itch Scale total score
Time Frame: From enrollment to the end of treatment at 8 weeks
The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.
Secondary Outcomes
- WI-NRS score(From the end of active treatment to the end of follow-up (4 weeks))
- Skindex-16 score(From the end of active treatment to the end of follow-up (4 weeks))
- Itch-MOS score(From the end of active treatment to the end of follow-up (4 weeks))
- 5D Elman Itch Scale total score(From the end of active treatment to the end of follow-up (4 weeks))
- C-reactive protein concentration(From enrollment to the end of treatment at 8 weeks)
- Serum ferritin(From enrollment to the end of treatment at 8 weeks)
Investigators
Ekaterina Parshina
Chief of Nephrology and Dialysis department
Saint Petersburg State University, Russia