Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
Information source: Angiotech Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: Central Venous Catheter (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Angiotech Pharmaceuticals Official(s) and/or principal investigator(s): Stephen Heard, MD, Principal Investigator, Affiliation: University of Mass. Medical School Department of Anesthesiology
Summary
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.
Clinical Details
Official title: A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Incidence of catheter colonization
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cardio-Thoracic Surgeons, P.C., Birmingham, Alabama 35235, United States
Pulmonary Consultant Group, Orange, California 92868, United States
Pulmonary Center Sharp Memorial Hospital, San Diego, California 92123, United States
Kaiser Permanente Santa Teresa, San Jose, California 95119, United States
Denver Health Medical Center, Denver, Colorado 80204, United States
Christiana Care Research Institute, Newark, Delaware 19713, United States
Florida Research Network, LLC, Gainesville, Florida 32605, United States
Atlanta Institute for Medical Research Inc, Decatur, Georgia 30030, United States
Kerry Thibodeaux, M.D., Opelousas, Louisiana 70570, United States
UMASS Medical School, Dept of Anesthesiology, Worcester, Massachusetts 01655, United States
Newark Beth Israel Hospital, Newark, New Jersey 07112, United States
Pulmonary and Critical Care Medicine, Cincinnati, Ohio 45267, United States
Medical University of Ohio, Toledo, Ohio 43614, United States
St Vincent Mercy Medical Center, Bldg 1, Toledo, Ohio 43608, United States
Universty of Oklahoma HSC, Oklahoma City, Oklahoma 73104, United States
Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States
University of Virginia, Department of Anesthesiology, Charlottesville, Virginia 22908, United States
Winchester Medical Center, Winchester, Virginia 22601, United States
Franciscan Health System Research Center, Tacoma, Washington 98405, United States
Additional Information
Starting date: December 2005
Last updated: January 22, 2013
|