Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in serum potassium
研究概览
简要总结
This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
Group A
60 patients will receive sodium zirconium cyclosilicate (SZC)
干预措施: sodium zirconium cyclosilicate (SZC) (Drug)
Group B
60 patients will receive sodium polystyrene sulfonate
干预措施: sodium polystyrene sulfonate (Drug)
结局指标
主要结局
Change in serum potassium
时间窗: 8 weeks
By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
次要结局
- Change in interdialytic weight(8 weeks)
- Gastrointestinal side effects(8 weeks)
- Change in Blood pressure(8 weeks)
- Serious adverse events(8 weeks)
研究者
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Alexandria University