Hyperkalemia Clinical Trial
Official title:
Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 15, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =3 month of maintenance hemodialysis, 3 times per week for 4 hours. 2. Adult patients with age above 18 years. 3. baseline serum potassium level >5 mEq/L. Exclusion Criteria: 1. Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis, perforation, ….). 2. Breast feeding or pregnancy. 3. Patients who receive medications to treat hyperkalemia 2 weeks before study. 4. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Aexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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. Erratum In: Core Evid. 2019 Feb 27;14:1. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum potassium | By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval | 4 weeks | |
Secondary | Change in interdialytic weight | By assessing change in interdialytic weight | 4 weeks | |
Secondary | Gastrointestinal side effects | By reporting any GIT SE | 4 weeks | |
Secondary | Change in Blood pressure | systolic and diastolic Blood pressure change | 4 weeks | |
Secondary | Serious adverse events | By reporting any serious adverse events. | 4 weeks |
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