Peritoneal DialysisIPMNCT05149508
Intraperitoneal Pressure Measurements in Children
An observational study of Peritoneal Dialysis, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Peritoneal Dialysis
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2021to 23 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
Study population: Minor subject (<18 years old) in stable peritoneal dialysis for more than 3 months and having had at least 3 IPP measurements
Who may be able to join
- 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.
Who cannot join
- -Subject (or his parents) having expressed his (their) opposition to participating in the stud
Trial locations and contacts
1 site in 1 country.
France1 site
Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Peritoneal Dialysis
- Keywords
- Peritoneal Dialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of good prescribing practices in children followed by peritoneal dialysis at Strasbourg University Hospital, by intraperitoneal pressure measurements
Measured: Files analysed retrospectively from January 01, 2001 to August 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start23 Sep 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149508
- Sponsor's protocol ID
- 8412
- Acronym
- IPM
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Pressure Measurements in Children: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05149508
- Acronym / sponsor ID
- IPM / 8412
- Conditions
- Peritoneal Dialysis
- Keywords
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Minor subject (<18 years old) in stable peritoneal dialysis for more than 3 months and having had at least 3 IPP measurements
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -Subject (or his parents) having expressed his (their) opposition to participating in the stud
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.