Novel Equation for Estimating Intraperitoneal Pressure

Peritoneal Dialysis Clinical Trial

Official title:

Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313841
• Other study ID #: IPP equation
• Status: Completed
• Start date: July 17, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis

Locations

Country	Name	City	State
China	Jie Dong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Novel equation development	Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients	July 17, 2021 to September 30, 2021
Primary	Novel equation validation	Validate the novel equation with intraperitoneal pressure obtained by Durand method	October 1,2021 to October 31,2021