Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 776
- 试验地点
- 16
- 主要终点
- T50 CIT values
研究概览
简要总结
This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.
详细描述
Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of blood. This pilot study aims to exploratory examine the predictive power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study shall investigate the association between baseline T50 CIT and fetuin-A values with CV related mortality, all-cause hospitalization and CV related hospitalization. Finally, the study aims to compare the predictive power of T50 CIT values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-A). After baseline blood sampling the patients will be followed for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Informed consent signed and dated by study patient and investigator/authorised physician
- •Minimum age of 18 years
- •Incident and prevalent haemodialysis patients
- •Three haemodialysis treatments per week
排除标准
- •Any condition which could interfere with the patient's ability to comply with the study
- •Pregnancy (pregnancy test will be conducted with female patients aged <= 55 years) or lactation period
- •Participation in an interventional clinical study during the preceding 30 days
结局指标
主要结局
T50 CIT values
时间窗: Baseline after signed informed consent
The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients.
次要结局
未报告次要终点