Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Dialysis Complication; Peritoneal Dialysis Access Failure
• Intervention / Treatment: Device: Peritoneal Catheter Insertion - Laparoscopic; Device: Peritoneal Catheter Insertion - Percutaneous

Detailed Description

Patient population and setting. 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.

Inclusion criteria: patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.

Exclusion criteria: patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded. Data source: ISPD Catheter Registry. The ISPD Catheter Registry is a web-based data collection tool that was custom-built for this project. It was developed based on a patented approach (Canadian patent #2,666,569; issued 2/28/2017)

Patient-level variables for our models will include baseline demographic (age, sex), comorbidity [body mass index (BMI), chronic kidney disease (dialysis-dependent vs. not), diabetes mellitus, cardiovascular disease (coronary artery disease, peripheral vascular disease, cerebrovascular disease), congestive heart failure, respiratory disease, liver disease, abdominal scarring, history of abdominal hernias], laboratory (hemoglobin, albumin), and medication variables (use of anticoagulants, antiplatelet, immunosuppressive medications).

Operator variables include operator volume, advanced training in PD catheter insertion and years of experience placing PD catheters.

Primary outcome: PD catheter complications. Our primary outcome will be the composite of the need for interventional procedures, emergency room visits and hospitalizations, reduction in time on PD, or discontinuation of PD therapy due to insertion-related PD catheter complications.

Sample size of 2,000 patients will provide 80% power to detect a 25% relative reduction in the risk of our primary outcome in those undergoing laparoscopic insertion of their catheter, across a range of possible ICC values. In order to guard against a larger than anticipated intra-class correlation coefficient(up to 0.001), we will target a sample size of 2,320 patients

• Study Type: Observational
• Enrollment (Anticipated): 2320

Contacts and Locations

• Study Contact: Name: Matthew Oliver, MD MHS; Phone Number: 416-480-4755; Email: matthew.oliver@sunnybrook.ca
• Study Contact Backup: Name: Susan Flanagan; Phone Number: 7148 416-480-6100; Email: Susan.Flanagan@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N1A4
      • Sunnybrook Health Sciences Centre
      • Contact: Matthew Oliver, MD MHS; Phone Number: 416-480-4755; Email: matthew.oliver@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.

Exclusion Criteria:patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic insertion; Individuals who undergo laparoscopic PD catheter insertion	Device: Peritoneal Catheter Insertion - Laparoscopic; Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure; Device: Peritoneal Catheter Insertion - Percutaneous; Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
Percutaneous insertion; Individuals who undergo percutaneous PD catheter insertion by either a nephrologist or radiologist.	Device: Peritoneal Catheter Insertion - Laparoscopic; Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure; Device: Peritoneal Catheter Insertion - Percutaneous; Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Matthew Oliver, MD MHS, University of Toronto

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 30, 2024

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (ACTUAL): July 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 160-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We would be willing to collaborate depending on the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No