CTRI/2023/05/052947尚未招募4 期
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
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female patients of age between 18 to 75 years both inclusive.
- •2. Patients hospitalised in intensive care units expected to require indwelling central venous catheterization for = 3 days (jugular
- •vein, subclavian vein, femoral vein).
- •3. 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
- •1. Patients with suspected catheter related infections.
- •2. Patients receiving an initial study catheter through guide wire exchange.
- •3. Patients with malignant diseases and unlikely to survive for the next 28 days in the opinion of the intensive care unit consultant;
- •4. Patients hospitalised for severe burn injuries;
- •5. Patient with a history of thrombocytopenia
- •6. Patient with a history of bleeding disorders
- •7. Patient with signs of infection, wounds and subcutaneous haematoma close to the puncture site
- •8. 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.
- •9. Current enrolment in a clinical study of any other unapproved investigational intravenous device within 30 days prior to signing informed consent.
- •10. Female patients who are pregnant or lactating.
研究者
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