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Due to Corona/Covid19 pandemic
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| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
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Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIP CVC | Experimental | Polyurethane CVC with noble metal coating |
|
| Standard CVC | Active Comparator | Standard CVC made of polyurethane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIP CVC | Device | Central venous access with noble metal coated CVC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with catheter related complications | Patients having any complication specified as secondary endpoints | From CVC insertion until CVC withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with CRBSI | CRBSI - Catheter Related Blood Stream Infections | From CVC insertion until CVC withdrawal |
| Number of patients with CRI | CRI - Catheter Related Infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Jakobsson, Prof | Danderyd Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Sjukhus | Stockholm | 18288 | Sweden |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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Pilot, randomized, open label, controlled trial
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| Standard CVC | Device | Central venous access with standard uncoated CVC |
|
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| From CVC insertion until CVC withdrawal |
| Number of patients with local CVC infections | Skin infection at the insertion site | From CVC insertion until CVC withdrawal |
| Number of CVC exchanges per patient due to suspected infection or thrombosis | Reported as incidence | From CVC insertion until CVC withdrawal |
| Number of patients with stop or slower flow in any CVC lumen | Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution | From CVC insertion until CVC withdrawal |
| Number of patients with local thrombosis | Local thrombosis - thrombosis in the insertion vein | From CVC insertion until CVC withdrawal |
| Number of patients with device malfunctions | Any device malfunction or technical problems during insertion, withdrawal or use | From CVC insertion until CVC withdrawal |
| Number of patients with antibiotics and antithrombotics drug use | including the reason of use and dose / number of days | From CVC insertion until CVC withdrawal |
| Number of patients with adverse events | including casuality assessment to the CVC use; both serious and non-serious | From CVC insertion until CVC withdrawal |