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

Primary Purpose

Central Venous Catheter, Catheter-Related Bloodstream Infection (CRBSI) Nos

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BioFlo DuraMax Chronic Hemodialysis Catheter
Standard of Care Catheter
Sponsored by
William Osler Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Central Venous Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • William Osler Health System
  • Halton Healthcare
  • Niagara Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard of Care Device

Study Device

Arm Description

Current standard of care polyurethane catheter used at the hospital

BioFlo DuraMax Chronic Hemodialysis Catheter

Outcomes

Primary Outcome Measures

Resource utilization related to hemodialysis catheter placement - tPA
vials of tPA utilized (unit)

Secondary Outcome Measures

Incidence of catheter-related complications
Includes thrombosis, infection, and any other catheter-related complications

Full Information

First Posted
March 20, 2017
Last Updated
October 31, 2019
Sponsor
William Osler Health System
Collaborators
Angiodynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03109574
Brief Title
Access in Dialysis for Better Outcomes in Patient Therapy
Acronym
ADOPT
Official Title
A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Osler Health System
Collaborators
Angiodynamics, Inc.

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Venous Catheter, Catheter-Related Bloodstream Infection (CRBSI) Nos

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Device
Arm Type
Other
Arm Description
Current standard of care polyurethane catheter used at the hospital
Arm Title
Study Device
Arm Type
Other
Arm Description
BioFlo DuraMax Chronic Hemodialysis Catheter
Intervention Type
Device
Intervention Name(s)
BioFlo DuraMax Chronic Hemodialysis Catheter
Intervention Type
Device
Intervention Name(s)
Standard of Care Catheter
Primary Outcome Measure Information:
Title
Resource utilization related to hemodialysis catheter placement - tPA
Description
vials of tPA utilized (unit)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of catheter-related complications
Description
Includes thrombosis, infection, and any other catheter-related complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Donnelly, MD
Organizational Affiliation
William Osler Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Halton Healthcare
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 0L8
Country
Canada
Facility Name
Niagara Health System
City
Saint Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Access in Dialysis for Better Outcomes in Patient Therapy

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