NCT05149508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

May 4, 2022

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 24, 2021

Last Update Submit

April 27, 2022

Conditions

Peritoneal Dialysis

Keywords

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (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

AgeUp to 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 8, 2021

Study Start

September 23, 2021

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

May 4, 2022

Record last verified: 2021-11

Locations

FR(1)