跳至主要内容
临床试验/NCT01839383
NCT01839383Unknown不适用

The Effects of Different Dialysate Calcium Concentration on Mineral-bone Metabolism in Chinese Patients on Maintenance Hemodialysis

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
death

研究概览

简要总结

The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12 months, iPTH 150-300pg/ml and serum calcium<2.5mmol/L. Patients were randomized to three groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25), 1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was performed for 4 hours three times weekly. Serum total calcium(tCa), ionized calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before and after the study and single dialysis session in every patient. iCa and P levels were measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP), osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP)and vascular calcification were measured in every patient periodically. vascular calcification including aortic arch calcification, abdominal aorta calcification and coronary artery calcification were measured by chest radiography, lateral lumbar radiographs and coronary artery computer tomography (CT) respectively. The primary endpoints included death, cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke), newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and valvular or vascular calcification. The secondary endpoint were admission or emergency observation.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium<2.5mmol/L, serum calcium<2.5mmol/L.

排除标准

  • Age<18 or >65 Severe acid-base disturbance History of parathyroid glands or adrenal gland combined with consumptions or malnutrition anemia due to acute bleeding or other diseases except for renal failure newly occurred bone fracture within 3 months active stage of immunological diseases using glucocorticoid or immunosuppressor combined with any disease with expect duration <2 year newly occurred acute heart failure, acute myocardial failure , acute cerebral infarction or stroke within 6 months pregnant women of women in preparation for pregnancy

结局指标

主要结局

death

时间窗: 24months

incidence of death

cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)

时间窗: 24months

incidence of cardio-cerebral vascular disease

newly nontraumatic bone fracture

时间窗: 24months

incidence of newly nontraumatic bone fracture

secondary hyperparathyroidism uncontrolled by medicine

时间窗: 24months

incidence of secondary hyperparathyroidism uncontrolled by medicine

valvular or vascular calcification

时间窗: 24months

incidence of valvular or vascular calcification

次要结局

  • admission or emergency observation(24months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenhu Liu

Professor

Beijing Friendship Hospital

研究点 (1)

Loading locations...

相似试验