Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization

A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters

The main purpose of this study is to determine if the Angiotech central venous catheter (CVC) is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization. Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream infection. This study will also assess the safety of the Angiotech CVC.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Device: Central Venous Catheter

Detailed Description

Central venous catheters are widely used for hemodynamic monitoring and the administration of fluids, drugs, and nutrition. The most frequent life-threatening complication of central venous catheter use is septicemia. Normal cutaneous flora may invade the intracutaneous tract during or after catheter insertion. The colonizing bacteria subsequently disseminate along the catheter surface and ultimately seed into the blood stream.

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.

• Study Type: Interventional
• Enrollment (Actual): 960
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Cardio-Thoracic Surgeons, P.C.
  • California
    • Orange, California, United States, 92868
      • Pulmonary Consultant Group
    • San Diego, California, United States, 92123
      • Pulmonary Center Sharp Memorial Hospital
    • San Jose, California, United States, 95119
      • Kaiser Permanente Santa Teresa
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Research Institute
  • Florida
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Atlanta Institute for Medical Research Inc
  • Louisiana
    • Opelousas, Louisiana, United States, 70570
      • Kerry Thibodeaux, M.D.
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMASS Medical School, Dept of Anesthesiology
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Pulmonary and Critical Care Medicine
    • Toledo, Ohio, United States, 43614
      • Medical University of Ohio
    • Toledo, Ohio, United States, 43608
      • St Vincent Mercy Medical Center, Bldg 1
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Universty of Oklahoma HSC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia, Department of Anesthesiology
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Franciscan Health System Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at least 18 years of age
• 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:

• Has a life expectancy of less than one month
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARROWgard Blue® CVC; 7-French x 20-cm, triple lumen, short-term CVC	Device: 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
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of catheter colonization	Primary Objective: The primary objective of this study was to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.	Maximum of 28 days

Collaborators and Investigators

• Sponsor: Angiotech Pharmaceuticals
• Investigators: Principal Investigator: Stephen Heard, MD, University of Mass. Medical School Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: February 6, 2006
• First Submitted That Met QC Criteria: February 6, 2006
• First Posted (Estimate): February 8, 2006

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Catheter related bloodstream infection; Colonization of the catheter
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: 011-ACVC05