An observational study in Peritoneal Dialysis, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Ottawa Hospital Research Institute · 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.
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
Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
Also known as: Observation
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.
Time frame: During laparoscopic surgery, up to 30 minutes
| Milestone | Study Participants |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Technology malfunction | 2 |
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.
| mm Hg | Study Participants |
|---|---|
| 15 mm Hg | -0.5 ± 2.0 |
| 10 mm Hg | -0.2 ± 3.1 |
| 5 mm Hg | -1.2 ± 2.6 |
Collected over During laparoscopic surgery, up to 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 4 |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 53 ± 15 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 3 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Study Participants |
|---|
| Region of Enrollment(participants) | Study Participants |
|---|---|
| Canada | 12 |
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Plan to share: No
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Ottawa Hospital Research Institute