Intraperitoneal PressureNCT05313841
Novel Equation for Estimating Intraperitoneal Pressure
An observational study of Intraperitoneal Pressure and Peritoneal Dialysis, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraperitoneal Pressure, Peritoneal Dialysis, Equation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2021to 31 Oct 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center
Who may be able to join
- Peritoneal dialysis patients
- Dialysis length >1 month
- Aged 18-80 years
- Injection volume of peritoneal dialysis solution>1500ml
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intraperitoneal Pressure, Peritoneal Dialysis, Equation
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel equation development
Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients
Measured: July 17, 2021 to September 30, 2021
Novel equation validation
Validate the novel equation with intraperitoneal pressure obtained by Durand method
Measured: October 1,2021 to October 31,2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start17 Jul 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraperitoneal PressureStudies 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313841
- Sponsor's protocol ID
- IPP equation
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT05313841
- Acronym / sponsor ID
- IPP equation
- Conditions
- Intraperitoneal Pressure, Peritoneal Dialysis, Equation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 6 Apr 2022 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center
Key inclusion criteria (4 listed)
- Peritoneal dialysis patients
- Dialysis length >1 month
- Aged 18-80 years
- Injection volume of peritoneal dialysis solution>1500ml
Key exclusion criteria (4 listed)
- 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
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
Novel equation development
Time frame: July 17, 2021 to September 30, 2021
Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients
Novel equation validation
Time frame: October 1,2021 to October 31,2021
Validate the novel equation with intraperitoneal pressure obtained by Durand method
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 6 Apr 2022.
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 Intraperitoneal Pressure and Peritoneal Dialysis, run by Peking University First Hospital at 1 site in China.
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 4 inclusion and 4 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 6 Apr 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 China. 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?
Novel equation development (time frame: July 17, 2021 to September 30, 2021). The study lists 2 primary outcomes in all. 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 6 Apr 2022; AzTrials last refreshed its copy on 28 Oct 2026.