Intra-abdominal Pressure in Peritoneal Dialysis Patients

Peritoneal Dialysis Clinical Trial

Official title:

Development of a Simplified Method to Measure Intra-abdominal Pressure in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811640
• Other study ID #: 20160377-01H
• Status: Completed
• Start date: June 30, 2016
• Est. completion date: April 25, 2019

Study information

• Verified date: October 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients treated with peritoneal dialysis (PD) are at increased risk of developing mechanical complications such as dialysate leaks and hernias thought to be related to an increase in intra-abdominal pressure (IAP) secondary to the addition of dialysate to the abdomen. Resistance training has been shown to increase IAP but it is unclear in the general population and in patients treated with PD if this training increases the risk of developing hernias. This study is observing the difference in IAP pressure measurements obtained by the Stryker intracompartmental (STIC) pressure monitor versus the standard IAP pressure measurements obtained with the insufflator at the time of PD catheter insertion.

Description:

Ten patients who are having a peritoneal dialysis (PD) catheter inserted at the Ottawa Hospital, and who provide informed consent, will undergo intra-abdominal pressure (IAP) measurements with the Stryker intracompartmental (STIC) pressure monitor. Values will be compared to the insufflator at inflation pressures 5,10, and 15 mmHg (millimeters of mercury). To determine if the Stryker pressure monitor is appropriate for measuring IAP in PD patients, the observed pressures will be analyzed with Bland Altman plots. If the mean difference between readings is 5 mmHg and 95% of the points fall within 2 standard deviations of the mean difference, the Stryker pressure monitor will be considered an acceptable method of measuring IAP. This tool will then be used as part of a future larger trial which will 1) measure IAP with resistance training in patients treated with PD; with and without dialysate, 2) assess PD patient interest in participating in resistance training trials and 3) determine the appropriateness of the proposed resistance training program for this patient population. The ultimate goal is to use this study to help inform and develop a clinical trial to 1) assess the impact of resistance training on quality of life and functional status, 2) assess the risk of developing leaks/hernias, and 3) determine if there is an association between IAP during resistance training and subsequent hernia development

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 25, 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>18 years old)
• Chronic kidney disease
• Will have a PD catheter inserted in the operating room at the Ottawa Hospital using laparoscopic surgery

Exclusion Criteria:

• Patients who will have a non-standard PD catheter insertion position (eg parasternal)

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Other:
• Study Participants
IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-Abdominal Pressure (IAP)	The Intra-Abdominal Pressure (IAP) measured with the Stryker monitor connected to the peritoneal dialysis (PD) catheter was compared with the insufflator pressures at of 15, 10, and 5 mm Hg.	During laparoscopic surgery, up to 30 minutes