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This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
Patients maintained on regular hemodialysis (HD) have a high risk of hyperkalemia (>5.0 mmol/l). Hyperkalemia is a critical medical condition that can result in arrhythmias and sudden cardiac death. Treatment of hyperkalemia in HD patients is challenging.
Therapeutic options for the treatment of hyperkalemia in HD population include potassium binding resins, such as sodium polystyrene sulfonate (SPS), patiromer, and sodium zirconium cyclosilicate. There is limited data about the use of these agents in HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 60 patients will receive sodium zirconium cyclosilicate (SZC) |
|
| Group B | Active Comparator | 60 patients will receive sodium polystyrene sulfonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium zirconium cyclosilicate (SZC) | Drug | 60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium | By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in interdialytic weight | By assessing change in interdialytic weight | 8 weeks |
| Gastrointestinal side effects | By reporting any GIT SE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mamdouh Elsayed, MD | lecturer | Principal Investigator |
| Marwa Ahmed Abdelrahman, MD | consultant | Study Chair |
| Mohamed Aly Abdelhalim, MD | Lecturer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Aexandria University | Alexandria | 21526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27592170 | Background | Yusuf AA, Hu Y, Singh B, Menoyo JA, Wetmore JB. Serum Potassium Levels and Mortality in Hemodialysis Patients: A Retrospective Cohort Study. Am J Nephrol. 2016;44(3):179-86. doi: 10.1159/000448341. Epub 2016 Sep 3. | |
| 29679302 | Background | Hoppe LK, Muhlack DC, Koenig W, Carr PR, Brenner H, Schottker B. Association of Abnormal Serum Potassium Levels with Arrhythmias and Cardiovascular Mortality: a Systematic Review and Meta-Analysis of Observational Studies. Cardiovasc Drugs Ther. 2018 Apr;32(2):197-212. doi: 10.1007/s10557-018-6783-0. |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000597310 | sodium zirconium cyclosilicate |
| C003321 | polystyrene sulfonic acid |
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This research is a prospective randomized multicentric clinical trial in which 120 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
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| sodium polystyrene sulfonate | Drug | 60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks. |
|
| 8 weeks |
| Change in Blood pressure | systolic and diastolic Blood pressure change | 8 weeks |
| Serious adverse events | By reporting any serious adverse events. | 8 weeks |
| 28356904 | Background | Beccari MV, Meaney CJ. Clinical utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene sulfonate for the treatment of hyperkalemia: an evidence-based review. Core Evid. 2017 Mar 23;12:11-24. doi: 10.2147/CE.S129555. eCollection 2017. |
| 30675431 | Background | Fried L, Kovesdy CP, Palmer BF. New options for the management of chronic hyperkalemia. Kidney Int Suppl (2011). 2017 Dec;7(3):164-170. doi: 10.1016/j.kisu.2017.09.001. Epub 2017 Nov 17. |
| 40329202 | Derived | Elsayed MM, Abdelrahman MA, Sorour AM, Rizk IG, Hassab MAA. Sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 May 6;26(1):227. doi: 10.1186/s12882-025-04129-9. |