Intra-abdominal Pressure in Peritoneal Dialysis Patients

NCT02811640 | Completed Results

• 1 other identifier: 20160377-01H
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis

Keywords

Intra-Abdominal Pressure; Stryker Pressure Monitor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Participants

Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital

Other: Study Participants

Interventions

Study Participants OTHER

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

Also known as: Observation

Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Limitations and Caveats

Technical problems with measurement leading to small sample size, and lack of a gold standard comparative may have affected our results. .

Results Point of Contact

• Title: Dr. Deborah Zimmerman
• Organization: Ottawa Hospital Research Institute

dzimmerman@toh.ca

613-738-8400

Study Officials

• Deborah Zimmerman, MD, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: June 30, 2016
• Primary Completion: September 1, 2017
• Study Completion: April 25, 2019
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)