Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

May 24, 2019 updated by: Nikoleta Printza, Baxter (Hellas) Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yiannis Ntotis
  • Phone Number: +302310892466

Study Locations

  • Greece
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • 1st ACADEMIC PEDIATRIC DEPARTMENT
        • Contact:
          • Nikoleta Printza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 20 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants, children and adolescent patients on chronic peritoneal dialysis

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Peritoneal Equilibration test profile
Time Frame: 1 year
Peritoneal Equilibration test
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of dialysis adequency
Time Frame: 1 year
KT/V
1 year
Elevated creatinine
Time Frame: 1 year
Creatinine Clearence
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter (Hellas) Ltd

Investigators

  • Principal Investigator: Nikoleta Printza, Aristotle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2019

Primary Completion (Anticipated)

April 22, 2020

Study Completion (Anticipated)

April 22, 2020

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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