A Cross-over Trial to Evaluate the Efficacy and Safety Between Increasing the Dose of Iron and Original Iron Dosage in Patients With Maintenance Hemodialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin>500ng/ml, or TSAT>20% to Ferritin> 800ng / ml, or TSAT> 50%.
详细描述
After two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receiving maintenance dialysis
排除标准
- •less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection
研究组 & 干预措施
Iron Treatment
Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%.
干预措施: irone sucrose (Drug)
结局指标
主要结局
Mortality
时间窗: 2 years
the death events following up until 2022
coronary artery disease
时间窗: 2 years
new onset coronary artery disease diagnosed with cardiac enzyme (\>troponins I upper limit 99%)
congestive heart failure
时间窗: 2 yearts
new onset congestive heart failure (brain natriuretic peptide\> 400pg/ml)
次要结局
- liver function(2 years)
- phospate(2 years)
- calcium(2 years)
- potassium(2 years)
- diabetes(2 years)
- nutrition status(2 years)
- anemia(2 years)
- sodium(2 years)
- parathyroid function(2 years)