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NCT03964701 Clinical Trial

Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03964701
Other study ID # 98550
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2019
Est. completion date April 22, 2020

Study information
Verified date May 2019
Source Baxter (Hellas) Ltd
Contact Nikoleta Printza
Phone +302310892466
Email nprintza@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date April 22, 2020
Est. primary completion date April 22, 2020
Accepts healthy volunteers
Gender All
Age group N/A to 20 Years
Eligibility Inclusion Criteria:

- Pediatric and adolescent patients on peritoneal dialysis

- Aged:1month -20 years

Exclusion Criteria:

-Abdominal surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no interventional study

Locations
Country Name City State
Greece 1st ACADEMIC PEDIATRIC DEPARTMENT Thessaloniki

Sponsors (1)
Lead Sponsor Collaborator
Baxter (Hellas) Ltd

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Peritoneal Equilibration test profile Peritoneal Equilibration test 1 year
Secondary Loss of dialysis adequency KT/V 1 year
Secondary Elevated creatinine Creatinine Clearence 1 year
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