CKD (Chronic Kidney Disease) Stage 5D, Hemodialysis, Pruritis
Conditions
Keywords
polymethylmethacrylate membranes, CKD-associated pruritis, PMMA membranes
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.
Interventions
DEVICEPolymethylmethacrylate membrane
A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
DEVICEpolysulfone membranes
Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5D Elman Itch Scale total score | 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
| Measure | Time frame | Description |
|---|---|---|
| Skindex-16 score | From enrollment to the end of treatment at 8 weeks | Multidimensional tool to assess pruritis |
| Itch-MOS score | From enrollment to the end of treatment at 8 weeks | Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep. |
| WI-NRS score | From enrollment to the end of treatment at 8 weeks | 24-hour Worst Itching Intensity Numerical Rating Scale |
| 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 | — |
| 5D Elman Itch Scale total score | From the end of active treatment to the end of follow-up (4 weeks) | — |
Countries
Russia
Contacts
Primary ContactEkaterina Parshina, PhD
Outcome results
None listed