A study to evaluate Performance and Safety of the Bactiguard Central Venous Catheter in seriously ill patients
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/05/052947
- Lead Sponsor
- Bactiguard AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of central line–associated bloodstream infection <br/ ><br>(CLABSI)Timepoint: 14 Days
- Secondary Outcome Measures
Name Time Method Duration of HospitalizationTimepoint: 14 Days;Duration of Stay in the Intensive Care Unit (ICU).Timepoint: 14 Days;Incidence of catheter-related thrombosis [Time Frame: From <br/ ><br>central venous catheter insertion until date of catheter removal]Timepoint: 14 Days;The incidence of CVC related adverse events (AEs) and <br/ ><br>severe adverse events (SAEs) from baseline to end of study.Timepoint: 14 Days