A Multicenter, Randomized, Parallel group, Open label, Post Marketing Clinical Investigation Study to assess efficacy and safety of Bactiguard® Central Venous Catheter (CVC) Compared to Standard Central Venous Catheter (CVC) in Critically ill Patients
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Incidence of central line–associated bloodstream infection
研究概览
简要总结
This study is A Multicenter, Randomized, Parallel group, Open label, Post Marketing Clinical Investigation Study to assess efficacy and safety of Bactiguard® Central Venous Catheter (CVC) compared to Standard Central Venous Catheter (CVC) in critically ill patients. 500 subjects will be enrolled in the study
The Objective is to evaluate the efficacy and safety of Bactiguard Central Venous Catheter (CVC) compared to Standard Central Venous Catheter (CVC) in critically ill patients.
All subjects will be assessed for primary endpoint i.e. Incidence of central line–associated bloodstream infection (CLABSI) from central venous catheter insertion until end of the study and secondary endpoint i.e. Incidence of CVC related adverse events (AEs) and severe adverse events (SAEs) from baseline to end of study, Incidence of catheter-related thrombosis from central venous catheter insertion until date of catheter removal ,Duration of Stay in the Intensive Care Unit (ICU) and Duration of Hospitalization
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of age between 18 to 75 years both inclusive.
- •Patients hospitalised in intensive care units expected to require indwelling central venous catheterization for ≥ 3 days (jugular vein, subclavian vein, femoral vein).
- •Patients or his/her legally authorized representative (if applicable) who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Patients with suspected catheter related infections.
- •Patients receiving an initial study catheter through guide wire exchange.
- •Patients with malignant diseases and unlikely to survive for the next 28 days in the opinion of the intensive care unit consultant;
- •Patients hospitalised for severe burn injuries;
- •Patient with a history of thrombocytopenia
- •Patient with a history of bleeding disorders
- •Patient with signs of infection, wounds and subcutaneous haematoma close to the puncture site
- •Patients with, in the opinion of the investigator, a situation that is not suitable for indwelling placement, including allergy to the catheter material, confirmed deep vein thrombosis and abnormal anatomical structure post-surgical changes in the insertion site.
- •Current enrolment in a clinical study of any other unapproved investigational intravenous device within 30 days prior to signing informed consent.
- •Female patients who are pregnant or lactating.
结局指标
主要结局
Incidence of central line–associated bloodstream infection
时间窗: 14 Days
(CLABSI)
时间窗: 14 Days
次要结局
- The incidence of CVC related adverse events (AEs) and(severe adverse events (SAEs) from baseline to end of study.)
- Incidence of catheter-related thrombosis [Time Frame: From(central venous catheter insertion until date of catheter removal])
- Duration of Hospitalization(14 Days)
- Duration of Stay in the Intensive Care Unit (ICU).(14 Days)