NCT05313841

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Intraperitoneal PressurePeritoneal DialysisEquation

Outcome Measures

Primary Outcomes (2)

  • Novel equation development

    Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients

    July 17, 2021 to September 30, 2021

  • Novel equation validation

    Validate the novel equation with intraperitoneal pressure obtained by Durand method

    October 1,2021 to October 31,2021

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center

You may qualify if:

  • Peritoneal dialysis patients
  • Dialysis length \>1 month
  • Aged 18-80 years
  • Injection volume of peritoneal dialysis solution\>1500ml

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie Dong

Beijing, Beijing Municipality, 100034, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor in Renal Division, Department of Medicine

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

July 17, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

CN(1)