Clinical trial NCT03976557: BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden
Official title: Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Complication
Catheter-Related Infections
Catheter Thrombosis
Catheter Blockage
Catheter Complications
Catheter Site Discomfort
Catheter Bacteraemia
Lead sponsor: Bactiguard AB
Sponsor class: INDUSTRY
Collaborators: name: Danderyd Hospital
First posted: 2019-06-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, randomized, open label, controlled trial
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with catheter related complications
timeFrame: From CVC insertion until CVC withdrawal
Secondary outcomes:
measure: Number of patients with CRBSI
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with CRI
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with local CVC infections
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of CVC exchanges per patient due to suspected infection or thrombosis
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with stop or slower flow in any CVC lumen
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with local thrombosis
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with device malfunctions
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with antibiotics and antithrombotics drug use
timeFrame: From CVC insertion until CVC withdrawal
measure: Number of patients with adverse events
timeFrame: From CVC insertion until CVC withdrawal
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Sjukhus
Study officials:
affiliation: Danderyd Hospital
name: Jan Jakobsson, Prof
role: PRINCIPAL_INVESTIGATOR
References: