Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

• Conditions: End Stage Renal Disease; Dialysis

• Registration Number: NCT03964701
• Lead Sponsor: Baxter (Hellas) Ltd

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.

Study Timeline

• Study Start: 2019-04-22
• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-24
• Last Update Submitted: 2019-05-24
• Study First Posted: 2019-05-28
• Last Update Posted: 2019-05-28
• Primary Completion: 2020-04-22
• Study Completion: 2020-04-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

-Abdominal surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Peritoneal Equilibration test profile	1 year	Peritoneal Equilibration test

Secondary Outcome Measures

Name	Time	Method
Loss of dialysis adequency	1 year	KT/V
Elevated creatinine	1 year	Creatinine Clearence

Trial Locations

Locations (1)

1st ACADEMIC PEDIATRIC DEPARTMENT; 🇬🇷 Thessaloniki, Greece