Access in Dialysis for Better Outcomes in Patient Therapy

Not Applicable

Completed

• Conditions: Catheter-Related Bloodstream Infection (CRBSI) Nos; Central Venous Catheter
• Interventions: Device: Standard of Care Catheter; Device: BioFlo DuraMax Chronic Hemodialysis Catheter

• Registration Number: NCT03109574
• Lead Sponsor: William Osler Health System

Brief Summary

This is a prospective, multi-center health economic study in Canada. Participants will be randomly assigned to receive either the study or control dialysis catheter. The primary objective is to evaluate resource utilization in Ontario related to hemodialysis catheter placement including tissue plasminogen activator (tPA) usage, catheter exchange rates, catheter patency, and missed dialysis days.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-29
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Is indicated for a dialysis catheter for the purpose of attaining long-term vascular access for hemodialysis. Long-term vascular access is defined by physician anticipated duration of hemodialysis for three months or longer.
• Is ≥ 18 years of age.
• Is indicated to receive dialysis treatment at a location where dialysis treatment data will be accessible by the study team.
• Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria

• Has known or suspected presence of other device-related infection, bacteremia, or septicemia or has been treated with antibiotics for documented or suspected infection within prior 45 days.
• Is receiving prophylactic anti-coagulation or anti-platelet pharmacotherapy for the purpose of central venous catheter (CVC) patency (anti-coagulation or anti-platelet pharmacotherapy for therapeutic indications do not exclude the patient from the study).
• Has severe chronic obstructive lung disease.
• Had past radiation therapy at the prospective insertion site.
• Had previous episodes of venous thrombosis or vascular surgical procedures at the prospective insertion site.
• Has local tissue factors that will prevent proper device stabilization and/or access.
• Has a stent placed in the vessel where the catheter will be placed
• Is pregnant
• History of drug or alcohol abuse in the past 12 months obtained from patient record and/or interview
• Subjects who weigh ≤ 30 kg.
• Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Device	Standard of Care Catheter	Current standard of care polyurethane catheter used at the hospital
Study Device	BioFlo DuraMax Chronic Hemodialysis Catheter	BioFlo DuraMax Chronic Hemodialysis Catheter

Primary Outcome Measures

Name	Time	Method
Resource utilization related to hemodialysis catheter placement - tPA	1 year	vials of tPA utilized (unit)

Secondary Outcome Measures

Name	Time	Method
Incidence of catheter-related complications	1 year	Includes thrombosis, infection, and any other catheter-related complications

Trial Locations

Locations (3)

William Osler Health System; 🇨🇦 Brampton, Ontario, Canada

Halton Healthcare; 🇨🇦 Oakville, Ontario, Canada

Niagara Health System; 🇨🇦 Saint Catharines, Ontario, Canada