Intra-abdominal Pressure in Peritoneal Dialysis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis
• Intervention / Treatment: Other: Study Participants

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients (>18 years old) with chronic kidney disease that will have a PD catheter inserted in the operating room at the Ottawa Hospital using laparoscopic surgery

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Participants; Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital	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; Other Names: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): April 25, 2019

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (ESTIMATE): June 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Intra-Abdominal Pressure; Stryker Pressure Monitor
• Other Study ID Numbers: 20160377-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO