Catheter Bacteraemia, Catheter Blockage, Catheter Complications, Catheter-Related Infections, Catheter Site Discomfort, Catheter Thrombosis, Vascular Access Complication
Conditions
Brief summary
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
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)
Interventions
DEVICEBIP CVC
Central venous access with noble metal coated CVC
DEVICEStandard CVC
Central venous access with standard uncoated CVC
Sponsors
Danderyd Hospital
Bactiguard AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot, randomized, open label, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…) 2. Fully recognize and understand patient information 3. Signed informed consent
Exclusion criteria
1. If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire 2. Age \< 18 years 3. Pregnant women 4. Known allergy to gold, silver and palladium 5. Participation in other clinical studies which may interfere with this study as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with catheter related complications | From CVC insertion until CVC withdrawal | Patients having any complication specified as secondary endpoints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with CRI | From CVC insertion until CVC withdrawal | CRI - Catheter Related Infections |
| Number of patients with local CVC infections | From CVC insertion until CVC withdrawal | Skin infection at the insertion site |
| Number of CVC exchanges per patient due to suspected infection or thrombosis | From CVC insertion until CVC withdrawal | Reported as incidence |
| Number of patients with stop or slower flow in any CVC lumen | From CVC insertion until CVC withdrawal | Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution |
| Number of patients with CRBSI | From CVC insertion until CVC withdrawal | CRBSI - Catheter Related Blood Stream Infections |
| Number of patients with device malfunctions | From CVC insertion until CVC withdrawal | Any device malfunction or technical problems during insertion, withdrawal or use |
| Number of patients with antibiotics and antithrombotics drug use | From CVC insertion until CVC withdrawal | including the reason of use and dose / number of days |
| Number of patients with adverse events | From CVC insertion until CVC withdrawal | including casuality assessment to the CVC use; both serious and non-serious |
| Number of patients with local thrombosis | From CVC insertion until CVC withdrawal | Local thrombosis - thrombosis in the insertion vein |
Countries
Sweden
Outcome results
None listed