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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMMA arm | Experimental | Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months. |
|
| Polysulfone arm | Active Comparator | Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymethylmethacrylate membrane | Device | A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| WI-NRS score | 24-hour Worst Itching Intensity Numerical Rating Scale | From enrollment to the end of treatment at 8 weeks |
| Skindex-16 score | Multidimensional tool to assess pruritis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekaterina Parshina, PhD | Contact | +7(921)6577372 | pannn@yandex.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Petersburg State University Hospital | Recruiting | Saint Petersburg | 198103 | Russia |
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| polysulfone membranes | Device | Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins. |
|
| From enrollment to the end of treatment at 8 weeks |
| Itch-MOS score | Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep. | 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) |
| 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) |
| 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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