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

NCT03976557 | Terminated

• 1 other identifier: PL-13732
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with catheter related complications

  Patients having any complication specified as secondary endpoints

  From CVC insertion until CVC withdrawal

Secondary Outcomes (9)

• Number of patients with CRBSI

  From CVC insertion until CVC withdrawal

• Number of patients with CRI

  From CVC insertion until CVC withdrawal

• Number of patients with local CVC infections

  From CVC insertion until CVC withdrawal

• Number of CVC exchanges per patient due to suspected infection or thrombosis

  From CVC insertion until CVC withdrawal

• Number of patients with stop or slower flow in any CVC lumen

  From CVC insertion until CVC withdrawal

Study Arms (2)

BIP CVC

EXPERIMENTAL

Polyurethane CVC with noble metal coating

Device: BIP CVC

Standard CVC

ACTIVE COMPARATOR

Standard CVC made of polyurethane

Device: Standard CVC

Interventions

BIP CVC DEVICE

Central venous access with noble metal coated CVC

Also known as: Noble metal coated CVC

BIP CVC

Standard CVC DEVICE

Central venous access with standard uncoated CVC

Also known as: Uncoated CVC

Standard CVC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bactiguard AB: lead
• Danderyd Hospital: collaborator

Study Sites (1)

Danderyd Sjukhus

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Jan Jakobsson, Prof

  Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, randomized, open label, controlled trial

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: April 11, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)