Intraperitoneal Pressure Measurements in Children (IPM)

April 27, 2022 updated by: University Hospital, Strasbourg, France

Intraperitoneal Pressure Measurements in Children: a Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

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

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg

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

No older than 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Minor subject (<18 years old) in stable peritoneal dialysis for more than 3 months and having had at least 3 IPP measurements

Description

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

September 23, 2021

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8412 (CTEP)

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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