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

Vascular Access Complication Clinical Trial

— IMPROWE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03976557
• Other study ID #: PL-13732
• Status: Terminated
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: January 2021
• Source: Bactiguard AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• BIP CVC
Central venous access with noble metal coated CVC
• Standard CVC
Central venous access with standard uncoated CVC

Locations

Country	Name	City	State
Sweden	Danderyd Sjukhus	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Bactiguard AB	Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with catheter related complications	Patients having any complication specified as secondary endpoints	From CVC insertion until CVC withdrawal
Secondary	Number of patients with CRBSI	CRBSI - Catheter Related Blood Stream Infections	From CVC insertion until CVC withdrawal
Secondary	Number of patients with CRI	CRI - Catheter Related Infections	From CVC insertion until CVC withdrawal
Secondary	Number of patients with local CVC infections	Skin infection at the insertion site	From CVC insertion until CVC withdrawal
Secondary	Number of CVC exchanges per patient due to suspected infection or thrombosis	Reported as incidence	From CVC insertion until CVC withdrawal
Secondary	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
Secondary	Number of patients with local thrombosis	Local thrombosis - thrombosis in the insertion vein	From CVC insertion until CVC withdrawal
Secondary	Number of patients with device malfunctions	Any device malfunction or technical problems during insertion, withdrawal or use	From CVC insertion until CVC withdrawal
Secondary	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
Secondary	Number of patients with adverse events	including casuality assessment to the CVC use; both serious and non-serious	From CVC insertion until CVC withdrawal