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IPM: Intraperitoneal Pressure Measurements in Children

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT05149508
Collaborator
(none)
21
Enrollment
1
Location
5.9
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pediatric peritoneal dialysis is prescribed according to the type of dialysis, the volume infused and the dialysis time. The measurement of intraperitoneal pressure (IPP) is an important and easy indicator to perform. A IPP greater than 18 cmH20 has been correlated with pain and dyspnea, a IPP greater than 14 has been correlated with a higher risk of peritonitis and a IPP greater than 13 was correlated with higher mortality and a switch on hemodialysis. These data suggest the importance of routine IPP measurement. Few data are available in the pediatric population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Intraperitoneal Pressure Measurements in Children: a Retrospective Study
    Actual Study Start Date :
    Sep 23, 2021
    Actual Primary Completion Date :
    Mar 23, 2022
    Actual Study Completion Date :
    Mar 23, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Study of good prescribing practices in children followed by peritoneal dialysis at Strasbourg University Hospital, by intraperitoneal pressure measurements [Files analysed retrospectively from January 01, 2001 to August 31, 2019 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Inclusion criteria:

    • Minor subject (<18 years old)

    • In stable peritoneal dialysis for more than 3 months

    • Subject having had at least 3 IPP measurements

    • At least 3 months after surgery to insert a peritoneal dialysis catheter

    • Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

    Exclusion criteria:
    • -Subject (or his parents) having expressed his (their) opposition to participating in the stud

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05149508
    Other Study ID Numbers:
    • 8412
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Peritoneal Dialysis

    Study Results

    No Results Posted as of May 4, 2022