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Clinical Trials/NCT02811640
NCT02811640
Completed
Not Applicable

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

Ottawa Hospital Research Institute1 site in 1 country12 target enrollmentJune 30, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peritoneal Dialysis
Sponsor
Ottawa Hospital Research Institute
Enrollment
12
Locations
1
Primary Endpoint
Intra-Abdominal Pressure (IAP)
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

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

Registry
clinicaltrials.gov
Start Date
June 30, 2016
End Date
April 25, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Intra-Abdominal Pressure (IAP)

Time Frame: During laparoscopic surgery, up to 30 minutes

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.

Study Sites (1)

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