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临床试验/NCT02697578
NCT02697578已完成不适用

Artificial Intelligence: to Analyse CKD-MBD in Hemodialysis and Cardiovascular Risk

Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
197
试验地点
1
主要终点
Change from Baseline Fibroblast growth factor 23 (pg/ml) at 24 months

研究概览

简要总结

The regulation of calcium, phosphate and parathyroid hormone in hemodialysis is complex and each parameter is not independently regulated. Simultaneous modification in these three parameters are the result of abnormal mineral metabolism and the treatment used. The specific objective of this work is an accurate and exhaustive analysis and description of the complex relationships between clinically relevant parameters in chronic kidney disease metabolism bone disease. In order to achieve these objectives we have used a machine learning approach Random Forest able to extract useful knowledge from a large database. The analysis of the complex interactions between the different parameters needs an advance mathematical approach such as Random Forest . The second aim of this study is to determine whether calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23 and calcitriol are long-term associated with demographic features, mortality, co-morbidity and the therapy prescribed. We will analyze in a prospective study on incident patients, whether the use of this new model may predict the cardiovascular risk..

详细描述

In hemodialysis patients, deviations of serum concentration of calcium, phosphate or parathyroid hormone from the values recommended by KDIGO are associated to a negative outcome. The regulation of calcium, phosphate and parathyroid hormone is complex and each parameter is not independently regulated. In hemodialysis patient's simultaneous modification in these three parameters are the result of abnormal mineral metabolism and the treatment used to correct these abnormalities that usually produce changes in more than one parameter. The specific objective of this work is an accurate and exhaustive analysis and description of the complex relationships between clinically relevant parameters in chronic kidney disease metabolism bone disease. In order to achieve these objectives we have used a machine learning approach Random Forest able to extract useful knowledge from a large database. The analysis of the complex interactions between the different parameters needs an advance mathematical approach such as Random Forest . The second aim of this study is to determine whether calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23 and calcitriol are long-term associated with demographic features, mortality, co-morbidity and the therapy prescribed. Compare the predictions obtained with conventional statistical analysis versus the new model analysis based on artificial intelligence. Our preliminary results suggest that there are interactions between some parameters that are strong enough to question whether the evaluation of a given therapy can be based in the measurement of one single parameter. Subsequently, we will analyze in a prospective study on incident patients, whether the use of this new model may predict the cardiovascular risk and reduce the therapy cost.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Incident hemodialysis patients
  • Non acute renal failure

排除标准

  • Previous treatment with cinacalcet
  • Neoplasia
  • Previous parathyrodectomy

结局指标

主要结局

Change from Baseline Fibroblast growth factor 23 (pg/ml) at 24 months

时间窗: Baseline, 24 months

Prospective analysis of fibroblast growth factor in a cohort of incident hemodialysis patients

次要结局

未报告次要终点

研究者

发起方
Maimónides Biomedical Research Institute of Córdoba
申办方类型
Other
责任方
Sponsor

研究点 (1)

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