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Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium cut-off | Active Comparator | Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers. |
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| High-flux | Active Comparator | High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium cut-off | Device | All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pre and post-dialysis of Interleukin (IL) 17-A | Comparison of pre and post-dialysis of IL-17A | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pre and post-dialysis of IL-10 | Comparison of pre and post-dialysis of IL-10 | 3 months |
| Comparison of pre and post-dialysis of Interferon (IFN) gama | Comparison of pre and post-dialysis of IFN gama |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Sevinc, MD | Sisli Hamidiye Etfal Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sisli Hamidiye Etfal Training and Research Hospital | Istanbul | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2018 | Feb 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| High-Flux | Device | All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min |
|
| 3 months |
| Comparison of pre and post-dialysis necrosis factor (TNF) alpha | Comparison of pre and post-dialysis of TNF alpha | 3 months |
| Comparison of pre and post-dialysis of IL-4 | Comparison of pre and post-dialysis of IL-4 | 3 months |
| Comparison of pre and post-dialysis of Urea | Comparison of pre and post-dialysis of Urea | 3 months |
| Comparison of pre and post-dialysis of creatinine | Comparison of pre and post-dialysis of creatinine | 3 months |
| Comparison of pre and post-dialysis of beta2 microglobulin | Comparison of pre and post-dialysis of beta2 microglobulin | 3 months |
| Comparison of pre and post-dialysis of free light chain kappa | Comparison of pre and post-dialysis of free light chain kappa | 3 months |
| Comparison of pre and post-dialysis of free light chain lambda | Comparison of pre and post-dialysis of free light chain lambda | 3 months |
| Comparison of pre and post-dialysis of myoglobulin | Comparison of pre and post-dialysis of myoglobulin | 3 months |
| Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23 | Comparison of pre and post-dialysis of FGF 23 | 3 months |
| Comparison of pre and post-dialysis IL-18 levels | Comparison of pre and post-dialysis IL-18 levels | 3 months |
| Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels | Comparison of pre and post-dialysis MCP-1 levels | 3 months |
| Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels | Comparison of pre and post-dialysis NLRP3 levels | 3 months |
| Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES) | Comparison of pre and post-dialysis RANTES | 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |