Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
- Conditions
- Bacterial Infections
- Interventions
- Device: Central Venous Catheter
- Registration Number
- NCT00288418
- Lead Sponsor
- Angiotech Pharmaceuticals
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 960
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiotech CVC Central Venous Catheter 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 ARROWgard Blue® CVC Central Venous Catheter 7-French x 20-cm, triple lumen, short-term CVC
- Primary Outcome Measures
Name Time Method Incidence of catheter colonization Maximum of 28 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Pulmonary Center Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Christiana Care Research Institute
🇺🇸Newark, Delaware, United States
Kerry Thibodeaux, M.D.
🇺🇸Opelousas, Louisiana, United States
Newark Beth Israel Hospital
🇺🇸Newark, New Jersey, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Cardio-Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente Santa Teresa
🇺🇸San Jose, California, United States
Atlanta Institute for Medical Research Inc
🇺🇸Decatur, Georgia, United States
Pulmonary and Critical Care Medicine
🇺🇸Cincinnati, Ohio, United States
Medical University of Ohio
🇺🇸Toledo, Ohio, United States
Universty of Oklahoma HSC
🇺🇸Oklahoma City, Oklahoma, United States
Pulmonary Consultant Group
🇺🇸Orange, California, United States
UMASS Medical School, Dept of Anesthesiology
🇺🇸Worcester, Massachusetts, United States
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
St Vincent Mercy Medical Center, Bldg 1
🇺🇸Toledo, Ohio, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
University of Virginia, Department of Anesthesiology
🇺🇸Charlottesville, Virginia, United States
Franciscan Health System Research Center
🇺🇸Tacoma, Washington, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States