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

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

    • Beijing
      • Beijing, Beijing, China, 100034
        • Jie Dong

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
October 1,2021 to October 31,2021

Collaborators and Investigators

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

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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