Hyperkalemia
Conditions
Keywords
Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate
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.
Interventions
60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks.
60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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. * Group A: 60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks. * Group B: 60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum potassium | 8 weeks | By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in interdialytic weight | 8 weeks | By assessing change in interdialytic weight |
| Gastrointestinal side effects | 8 weeks | By reporting any GIT SE |
| Change in Blood pressure | 8 weeks | systolic and diastolic Blood pressure change |
| Serious adverse events | 8 weeks | By reporting any serious adverse events. |
Countries
Egypt
Outcome results
None listed