Access in Dialysis for Better Outcomes in Patient Therapy (ADOPT)

William Osler Health System

Status

Completed

Conditions

Catheter-Related Bloodstream Infection (CRBSI) Nos

Central Venous Catheter

Treatments

Device: Standard of Care Catheter

Device: BioFlo DuraMax Chronic Hemodialysis Catheter

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03109574

VA-BF410

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.