Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
NCT ID: NCT00288418
Last Updated: 2013-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
960 participants
INTERVENTIONAL
2005-12-31
2007-07-31
Brief Summary
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Detailed Description
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In the United States, a total of 250,000 cases of central venous catheter-related infections are estimated annually. Costs per infection are estimated as high as US$56,000. It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance.
Primary Objective: The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.
Secondary Objectives: The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue® CVC to prevent:
1. catheter-related local infection; and
2. catheter-related bloodstream infection.
Safety Objectives: This study will assess the safety of the Angiotech CVC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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ARROWgard Blue® CVC
7-French x 20-cm, triple lumen, short-term CVC
Central Venous Catheter
7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
Angiotech CVC
A 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
Central Venous Catheter
7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
Interventions
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Central Venous Catheter
7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
Eligibility Criteria
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Inclusion Criteria
* Be initially hospitalized in an intensive care setting
* Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
* If female and of child-bearing potential, provide evidence of a negative pregnancy test
Exclusion Criteria
* Is pregnant
* Has a history of anaphylactic reactions, including reactions to contrast dyes
* Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine
18 Years
ALL
No
Sponsors
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Angiotech Pharmaceuticals
INDUSTRY
Responsible Party
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Angiotech
Principal Investigators
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Stephen Heard, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mass. Medical School Department of Anesthesiology
Locations
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Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States
Pulmonary Consultant Group
Orange, California, United States
Pulmonary Center Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente Santa Teresa
San Jose, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Christiana Care Research Institute
Newark, Delaware, United States
Florida Research Network, LLC
Gainesville, Florida, United States
Atlanta Institute for Medical Research Inc
Decatur, Georgia, United States
Kerry Thibodeaux, M.D.
Opelousas, Louisiana, United States
UMASS Medical School, Dept of Anesthesiology
Worcester, Massachusetts, United States
Newark Beth Israel Hospital
Newark, New Jersey, United States
Pulmonary and Critical Care Medicine
Cincinnati, Ohio, United States
St Vincent Mercy Medical Center, Bldg 1
Toledo, Ohio, United States
Medical University of Ohio
Toledo, Ohio, United States
Universty of Oklahoma HSC
Oklahoma City, Oklahoma, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, United States
Winchester Medical Center
Winchester, Virginia, United States
Franciscan Health System Research Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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011-ACVC05
Identifier Type: -
Identifier Source: org_study_id
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