Artificial Intelligence: a New Alternative to Analyse CKD-MBD in Hemodialysis

NCT02697578 | Completed

• 1 other identifier: PI-0311-2014
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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..

Conditions

Chronic Kidney Disease Mineral and Bone Disorder

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, 24 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Incident hemodialysis patients

You may qualify if:

• Incident hemodialysis patients
• Non acute renal failure

You may not qualify if:

• Previous treatment with cinacalcet
• Neoplasia
• Previous parathyrodectomy

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pre-dialysis blood samples

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alejandro Martín Malo, MD

  Andalusian Public Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 3, 2016
• Study Start: February 1, 2016
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

ES (1)