- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313841
Novel Equation for Estimating Intraperitoneal Pressure
March 29, 2022 updated by: Dong Jie, Peking University First Hospital
Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients
Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients.
Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients.
There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited.
In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
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
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Beijing
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Beijing, Beijing, China, 100034
- Jie Dong
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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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center
Description
Inclusion Criteria:
- Peritoneal dialysis patients
- Dialysis length >1 month
- Aged 18-80 years
- Injection volume of peritoneal dialysis solution>1500ml
Exclusion Criteria:
- Acute complications ( peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study
- History of abdominal surgery and trauma 1 month prior to the study
- Previous history of hernia, leakage, or thoracoabdominal fistula
- Can't come for a follow-up visit
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Novel equation development
Time Frame: July 17, 2021 to September 30, 2021
|
Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients
|
July 17, 2021 to September 30, 2021
|
|
Novel equation validation
Time Frame: October 1,2021 to October 31,2021
|
Validate the novel equation with intraperitoneal pressure obtained by Durand method
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October 1,2021 to October 31,2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 17, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
March 29, 2022
First Submitted That Met QC Criteria
March 29, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IPP equation
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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