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Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

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ClinicalTrials.gov Identifier: NCT03964701
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Nikoleta Printza, Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment
End Stage Renal Disease Dialysis Other: no intervention

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.

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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : April 22, 2020
Estimated Study Completion Date : April 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • Other: no intervention
    no interventional study


Primary Outcome Measures :
  1. Change of Peritoneal Equilibration test profile [ Time Frame: 1 year ]
    Peritoneal Equilibration test


Secondary Outcome Measures :
  1. Loss of dialysis adequency [ Time Frame: 1 year ]
    KT/V

  2. Elevated creatinine [ Time Frame: 1 year ]
    Creatinine Clearence


Biospecimen Retention:   Samples Without DNA
Peritoneal dialysis PD effluent, blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Infants, children and adolescent patients on chronic peritoneal dialysis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-Abdominal surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964701


Contacts
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Contact: Nikoleta Printza +302310892466 nprintza@gmail.com
Contact: Yiannis Ntotis +302310892466

Locations
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Greece
1st ACADEMIC PEDIATRIC DEPARTMENT Recruiting
Thessaloniki, Greece, 546 36
Contact: Nikoleta Printza         
Sponsors and Collaborators
Baxter (Hellas) Ltd
Investigators
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Principal Investigator: Nikoleta Printza Aristotle University
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Responsible Party: Nikoleta Printza, Associate Prof in Paediatric Nephrology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03964701    
Other Study ID Numbers: 98550
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nikoleta Printza, Aristotle University Of Thessaloniki:
children
renal failure
dialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency