Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion
1 other identifier
observational
2,320
1 country
1
Brief Summary
Peritoneal dialysis (PD) is actively promoted as the preferred form of dialysis for patients with kidney failure. However, 1 in 5 patients will experience a signification catheter insertion-related PD catheter complication in the first 6 months following insertion. Little is known about the patient-, operator-, and center-level factors that influence PD catheter complications. There is a need to identify key modifiable practices to focus randomized trials and quality improvement efforts. We will leverage prior funding, a custom-built data collection platform, pilot data, and a group of engaged stakeholders, partners, and knowledge users to: a) Determine if method of insertion is associated with PD catheter complications b) Identify operator/center characteristics and practices associated with PD catheter complications c) Use a data-driven approach to achieve expert consensus on optimal practices for PD catheter insertion and care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedJuly 26, 2019
July 1, 2019
3.3 years
July 24, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Insertion related complications
Complications (exit site leak, flow restriction, pain, infection, bleeding) likely associated with the method of insertion
1 year following the start of PD therapy
Study Arms (2)
Laparoscopic insertion
Individuals who undergo laparoscopic PD catheter insertion
Percutaneous insertion
Individuals who undergo percutaneous PD catheter insertion by either a nephrologist or radiologist.
Interventions
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
Eligibility Criteria
We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N1A4, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Oliver, MD MHS
University of Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 26, 2019
Study Start
September 1, 2019
Primary Completion
December 31, 2022
Study Completion
March 30, 2024
Last Updated
July 26, 2019
Record last verified: 2019-07