BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden (IMPROWE)

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

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)

Study Overview

• Status: Terminated
• Conditions: Catheter-Related Infections; Catheter Bacteraemia; Vascular Access Complication; Catheter Complications; Catheter Site Discomfort; Catheter Blockage; Catheter Thrombosis
• Intervention / Treatment: Device: BIP CVC; Device: Standard CVC

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Danderyd Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BIP CVC; Polyurethane CVC with noble metal coating	Device: BIP CVC; Central venous access with noble metal coated CVC; Other Names: Noble metal coated CVC
ACTIVE_COMPARATOR: Standard CVC; Standard CVC made of polyurethane	Device: Standard CVC; Central venous access with standard uncoated CVC; Other Names: Uncoated CVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with catheter related complications	Patients having any complication specified as secondary endpoints	From CVC insertion until CVC withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with CRBSI	CRBSI - Catheter Related Blood Stream Infections	From CVC insertion until CVC withdrawal
Number of patients with CRI	CRI - Catheter Related Infections	From CVC insertion until CVC withdrawal
Number of patients with local CVC infections	Skin infection at the insertion site	From CVC insertion until CVC withdrawal
Number of CVC exchanges per patient due to suspected infection or thrombosis	Reported as incidence	From CVC insertion until CVC withdrawal
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
Number of patients with local thrombosis	Local thrombosis - thrombosis in the insertion vein	From CVC insertion until CVC withdrawal
Number of patients with device malfunctions	Any device malfunction or technical problems during insertion, withdrawal or use	From CVC insertion until CVC withdrawal
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
Number of patients with adverse events	including casuality assessment to the CVC use; both serious and non-serious	From CVC insertion until CVC withdrawal

Collaborators and Investigators

• Sponsor: Bactiguard AB
• Collaborators: Danderyd Hospital
• Investigators: Principal Investigator: Jan Jakobsson, Prof, Danderyd Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2019
• Primary Completion (ACTUAL): December 18, 2019
• Study Completion (ACTUAL): December 18, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Embolism and Thrombosis; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Thrombosis; Catheter-Related Infections
• Other Study ID Numbers: PL-13732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No