BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

Official Title
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Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol

Conditions
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Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis, Catheter Blockage, Catheter Complications, Catheter Site Discomfort, Catheter Bacteraemia

Intervention / Treatment
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* Device: BIP CVC
* Device: Standard CVC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…) Fully recognize and understand patient information Signed informed consent Exclusion Criteria: If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire Age < 18 years Pregnant women Known allergy to gold, silver and palladium Participation in other clinical studies which may interfere with this study as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot, randomized, open label, controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIP CVC<br>Polyurethane CVC with noble metal coating | Device: BIP CVC<br>* Central venous access with noble metal coated CVC<br>* Other names: Noble metal coated CVC;|
| Active Comparator: Standard CVC<br>Standard CVC made of polyurethane | Device: Standard CVC<br>* Central venous access with standard uncoated CVC<br>* Other names: Uncoated CVC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |