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

Not Applicable

Terminated

• Conditions: Catheter Site Discomfort; Catheter Bacteraemia; Catheter-Related Infections; Catheter Thrombosis; Vascular Access Complication; Catheter Blockage; Catheter Complications
• Interventions: Device: BIP CVC; Device: Standard CVC

• Registration Number: NCT03976557
• Lead Sponsor: Bactiguard AB

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)

Study Timeline

• Study Start: 2019-04-11
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIP CVC	BIP CVC	Polyurethane CVC with noble metal coating
Standard CVC	Standard CVC	Standard CVC made of polyurethane

Primary Outcome Measures

Name	Time	Method
Number of patients with catheter related complications	From CVC insertion until CVC withdrawal	Patients having any complication specified as secondary endpoints

Secondary Outcome Measures

Name	Time	Method
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 device malfunctions	From CVC insertion until CVC withdrawal	Any device malfunction or technical problems during insertion, withdrawal or use
Number of patients with local thrombosis	From CVC insertion until CVC withdrawal	Local thrombosis - thrombosis in the insertion vein
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 CRBSI	From CVC insertion until CVC withdrawal	CRBSI - Catheter Related Blood Stream Infections
Number of patients with CRI	From CVC insertion until CVC withdrawal	CRI - Catheter Related Infections
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 local CVC infections	From CVC insertion until CVC withdrawal	Skin infection at the insertion site
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

Trial Locations

Locations (1)

Danderyd Sjukhus; 🇸🇪 Stockholm, Sweden