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

Primary Purpose

Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
BIP CVC
Standard CVC
Sponsored by
Bactiguard AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Access Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danderyd Sjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIP CVC

Standard CVC

Arm Description

Polyurethane CVC with noble metal coating

Standard CVC made of polyurethane

Outcomes

Primary Outcome Measures

Number of patients with catheter related complications
Patients having any complication specified as secondary endpoints

Secondary Outcome Measures

Number of patients with CRBSI
CRBSI - Catheter Related Blood Stream Infections
Number of patients with CRI
CRI - Catheter Related Infections
Number of patients with local CVC infections
Skin infection at the insertion site
Number of CVC exchanges per patient due to suspected infection or thrombosis
Reported as incidence
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
Number of patients with local thrombosis
Local thrombosis - thrombosis in the insertion vein
Number of patients with device malfunctions
Any device malfunction or technical problems during insertion, withdrawal or use
Number of patients with antibiotics and antithrombotics drug use
including the reason of use and dose / number of days
Number of patients with adverse events
including casuality assessment to the CVC use; both serious and non-serious

Full Information

First Posted
June 4, 2019
Last Updated
January 19, 2021
Sponsor
Bactiguard AB
Collaborators
Danderyd Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03976557
Brief Title
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden
Acronym
IMPROWE
Official Title
Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to Corona/Covid19 pandemic
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bactiguard AB
Collaborators
Danderyd Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis, Catheter Blockage, Catheter Complications, Catheter Site Discomfort, Catheter Bacteraemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, randomized, open label, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIP CVC
Arm Type
Experimental
Arm Description
Polyurethane CVC with noble metal coating
Arm Title
Standard CVC
Arm Type
Active Comparator
Arm Description
Standard CVC made of polyurethane
Intervention Type
Device
Intervention Name(s)
BIP CVC
Other Intervention Name(s)
Noble metal coated CVC
Intervention Description
Central venous access with noble metal coated CVC
Intervention Type
Device
Intervention Name(s)
Standard CVC
Other Intervention Name(s)
Uncoated CVC
Intervention Description
Central venous access with standard uncoated CVC
Primary Outcome Measure Information:
Title
Number of patients with catheter related complications
Description
Patients having any complication specified as secondary endpoints
Time Frame
From CVC insertion until CVC withdrawal
Secondary Outcome Measure Information:
Title
Number of patients with CRBSI
Description
CRBSI - Catheter Related Blood Stream Infections
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with CRI
Description
CRI - Catheter Related Infections
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with local CVC infections
Description
Skin infection at the insertion site
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of CVC exchanges per patient due to suspected infection or thrombosis
Description
Reported as incidence
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with stop or slower flow in any CVC lumen
Description
Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with local thrombosis
Description
Local thrombosis - thrombosis in the insertion vein
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with device malfunctions
Description
Any device malfunction or technical problems during insertion, withdrawal or use
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with antibiotics and antithrombotics drug use
Description
including the reason of use and dose / number of days
Time Frame
From CVC insertion until CVC withdrawal
Title
Number of patients with adverse events
Description
including casuality assessment to the CVC use; both serious and non-serious
Time Frame
From CVC insertion until CVC withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Jakobsson, Prof
Organizational Affiliation
Danderyd Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Sjukhus
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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