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.
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;
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.
Parallel
Polymethylmethacrylate membrane
DeviceA polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
polysulfone membranes
DeviceDialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.
5D Elman Itch Scale total score
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.
WI-NRS score
24-hour Worst Itching Intensity Numerical Rating Scale
Skindex-16 score
Multidimensional tool to assess pruritis
Itch-MOS score
Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.
5D Elman Itch Scale total score
Click on the lead sponsor to view all of their trials.
