Status:
COMPLETED
Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
Lead Sponsor:
Angiotech Pharmaceuticals
Conditions:
Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 bacteri...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT00288418
Start Date
December 1 2005
End Date
July 1 2007
Last Update
January 23 2013
Active Locations (21)
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1
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35235
2
Pulmonary Consultant Group
Orange, California, United States, 92868
3
Pulmonary Center Sharp Memorial Hospital
San Diego, California, United States, 92123
4
Kaiser Permanente Santa Teresa
San Jose, California, United States, 95119