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Clinical Trials/NCT03964701
NCT03964701
Unknown
Not Applicable

Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis

Baxter (Hellas) Ltd1 site in 1 country18 target enrollmentApril 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Baxter (Hellas) Ltd
Enrollment
18
Locations
1
Primary Endpoint
Change of Peritoneal Equilibration test profile
Last Updated
6 years ago

Overview

Brief Summary

Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis

Detailed Description

Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice. Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane. Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible). Improve PD survival in infants and children.

Registry
clinicaltrials.gov
Start Date
April 22, 2019
End Date
April 22, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Baxter (Hellas) Ltd
Responsible Party
Principal Investigator
Principal Investigator

Nikoleta Printza

Associate Prof in Paediatric Nephrology

Aristotle University Of Thessaloniki

Eligibility Criteria

Inclusion Criteria

  • Pediatric and adolescent patients on peritoneal dialysis
  • Aged:1month -20 years

Exclusion Criteria

  • Abdominal surgery

Outcomes

Primary Outcomes

Change of Peritoneal Equilibration test profile

Time Frame: 1 year

Peritoneal Equilibration test

Secondary Outcomes

  • Loss of dialysis adequency(1 year)
  • Elevated creatinine(1 year)

Study Sites (1)

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