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NCT05149508 Clinical Trial

Intraperitoneal Pressure Measurements in Children

Peritoneal Dialysis Clinical Trial

— IPM  

Official title:
Intraperitoneal Pressure Measurements in Children: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05149508
Other study ID # 8412
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2021
Est. completion date March 23, 2022

Study information
Verified date November 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 23, 2022
Est. primary completion date March 23, 2022
Accepts healthy volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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]
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