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Intra-abdominal Pressure in Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT02811640
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.


Condition or disease Intervention/treatment
Peritoneal Dialysis 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 Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of a Simplified Method to Measure Intra-abdominal Pressure in Peritoneal Dialysis Patients
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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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 Name: Observation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811640


Locations
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Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Deborah Zimmerman, MD, MSc Ottawa Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by Ottawa Hospital Research Institute:
Study Protocol and Statistical Analysis Plan  [PDF] July 25, 2017

More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02811640    
Other Study ID Numbers: 20160377-01H
First Posted: June 23, 2016    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: November 18, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ottawa Hospital Research Institute:
Intra-Abdominal Pressure
Stryker Pressure Monitor