Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Bactiguard Central Venous Catheter (CVC): upto 14 days
Control Intervention1: Standard Central Venous Catheter (CVC): Upto 14 Days
Sponsors
Bactiguard AB
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of central line–associated bloodstream infection (CLABSI)Timepoint: 14 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of CVC related adverse events (AEs) and severe adverse events (SAEs) from baseline to end of study.Timepoint: 14 Days;Incidence of catheter-related thrombosis [Time Frame: From central venous catheter insertion until date of catheter removal]Timepoint: 14 Days;Duration of Stay in the Intensive Care Unit (ICU).Timepoint: 14 Days;Duration of HospitalizationTimepoint: 14 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt. Ltd
Outcome results
None listed