The First Affiliated Hospital of Chongqing Medical University
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in coronary artery calcification after 1 year's treatment
研究概览
简要总结
This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.
详细描述
MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH <500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
- •Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
- •Patients who signed informed consent documents at the time of enrollment in the study.
排除标准
- •Patients whose heart or lung function are poor, or with unstable hemodynamics.
- •Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
- •Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.
结局指标
主要结局
Changes in coronary artery calcification after 1 year's treatment
时间窗: 1 year
次要结局
- The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study(1 year)
研究者
Yunfeng Xia
Department of Nephrology
First Affiliated Hospital of Chongqing Medical University