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Clinical Trials/NCT02697578
NCT02697578CompletedNot Applicable

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

Maimónides Biomedical Research Institute of Córdoba1 site in 1 country197 target enrollmentStarted: February 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
197
Locations
1
Primary Endpoint
Change from Baseline Fibroblast growth factor 23 (pg/ml) at 24 months

Study Overview

Brief Summary

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..

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Incident hemodialysis patients
  • Non acute renal failure

Exclusion Criteria

  • Previous treatment with cinacalcet
  • Neoplasia
  • Previous parathyrodectomy

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 24 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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