A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 960
- 试验地点
- 42
- 主要终点
- Incidence of catheter colonization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ARROWgard Blue® CVC
7-French x 20-cm, triple lumen, short-term CVC
干预措施: Central Venous Catheter (Device)
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
干预措施: Central Venous Catheter (Device)
结局指标
主要结局
Incidence of catheter colonization
时间窗: 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.
次要结局
未报告次要终点