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

Sponsor

Angiotech Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00288418

Collaborator

(none)

960

Enrollment

Locations

Arms

Duration (Months)

45.7

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Device: Central Venous Catheter	Phase 3

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:

catheter-related local infection; and
catheter-related bloodstream infection.

Safety Objectives: This study will assess the safety of the Angiotech CVC.

Study Design

Study Type:

Interventional

Actual Enrollment :

960 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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 Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Denver Health Medical Center	Denver	Colorado	United States	80204
6	Christiana Care Research Institute	Newark	Delaware	United States	19713
7	Florida Research Network, LLC	Gainesville	Florida	United States	32605
8	Atlanta Institute for Medical Research Inc	Decatur	Georgia	United States	30030
9	Kerry Thibodeaux, M.D.	Opelousas	Louisiana	United States	70570
10	UMASS Medical School, Dept of Anesthesiology	Worcester	Massachusetts	United States	01655
11	Newark Beth Israel Hospital	Newark	New Jersey	United States	07112
12	Pulmonary and Critical Care Medicine	Cincinnati	Ohio	United States	45267
13	St Vincent Mercy Medical Center, Bldg 1	Toledo	Ohio	United States	43608
14	Medical University of Ohio	Toledo	Ohio	United States	43614
15	Universty of Oklahoma HSC	Oklahoma City	Oklahoma	United States	73104
16	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
17	Rhode Island Hospital	Providence	Rhode Island	United States	02903
18	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
19	University of Virginia, Department of Anesthesiology	Charlottesville	Virginia	United States	22908
20	Winchester Medical Center	Winchester	Virginia	United States	22601
21	Franciscan Health System Research Center	Tacoma	Washington	United States	98405

Sponsors and Collaborators

Angiotech Pharmaceuticals

Investigators

Principal Investigator: Stephen Heard, MD, University of Mass. Medical School Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00288418

Other Study ID Numbers:

011-ACVC05

First Posted:

Feb 8, 2006

Last Update Posted:

Jan 23, 2013

Last Verified:

Jan 1, 2013

Keywords provided by , ,

Colonization of the catheter

Catheter related bloodstream infection

Additional relevant MeSH terms:

Bacterial Infections

Study Results

No Results Posted as of Jan 23, 2013