Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion

Peritoneal Dialysis Complication Clinical Trial

Official title:

Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04034628
• Other study ID #: 160-2019
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: March 30, 2024

Study information

• Verified date: July 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: Matthew Oliver, MD MHS
• Phone: 416-480-4755
• Email: matthew.oliver[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2320
• Est. completion date: March 30, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis Access Failure
• Peritoneal Dialysis Complication

Intervention

Device:
• Peritoneal Catheter Insertion - Laparoscopic
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
• Peritoneal Catheter Insertion - Percutaneous
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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