Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in serum potassium
Study Overview
Brief Summary
This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥3 month of maintenance hemodialysis, 3 times per week for 4 hours.
- •Adult patients with age above 18 years.
- •baseline serum potassium level >5 mEq/L.
Exclusion Criteria
- •Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis, perforation, ....).
- •Breast feeding or pregnancy.
- •Patients who receive medications to treat hyperkalemia 2 weeks before study.
- •myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study.
Arms & Interventions
Group A
60 patients will receive sodium zirconium cyclosilicate (SZC)
Intervention: sodium zirconium cyclosilicate (SZC) (Drug)
Group B
60 patients will receive sodium polystyrene sulfonate
Intervention: sodium polystyrene sulfonate (Drug)
Outcomes
Primary Outcomes
Change in serum potassium
Time Frame: 8 weeks
By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
Secondary Outcomes
- Change in interdialytic weight(8 weeks)
- Gastrointestinal side effects(8 weeks)
- Change in Blood pressure(8 weeks)
- Serious adverse events(8 weeks)
Investigators
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Alexandria University