Peritoneal Dialysis Clinical Trial
Official title:
Development of a Simplified Method to Measure Intra-abdominal Pressure in Peritoneal Dialysis Patients
NCT number | NCT02811640 |
Other study ID # | 20160377-01H |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2016 |
Est. completion date | April 25, 2019 |
Verified date | October 2020 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
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 |
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