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

Sponsor
Bactiguard AB (Industry)
Overall Status
Terminated
CT.gov ID
NCT03976557
Collaborator
Danderyd Hospital (Other)
19
Enrollment
1
Location
2
Arms
8.2
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Device: BIP CVC
  • Device: Standard CVC
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot, randomized, open label, controlled trialPilot, randomized, open label, controlled trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
Actual Study Start Date :
Apr 11, 2019
Actual Primary Completion Date :
Dec 18, 2019
Actual Study Completion Date :
Dec 18, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with catheter related complications [From CVC insertion until CVC withdrawal]

      Patients having any complication specified as secondary endpoints

    Secondary Outcome Measures

    1. Number of patients with CRBSI [From CVC insertion until CVC withdrawal]

      CRBSI - Catheter Related Blood Stream Infections

    2. Number of patients with CRI [From CVC insertion until CVC withdrawal]

      CRI - Catheter Related Infections

    3. Number of patients with local CVC infections [From CVC insertion until CVC withdrawal]

      Skin infection at the insertion site

    4. Number of CVC exchanges per patient due to suspected infection or thrombosis [From CVC insertion until CVC withdrawal]

      Reported as incidence

    5. 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

    6. Number of patients with local thrombosis [From CVC insertion until CVC withdrawal]

      Local thrombosis - thrombosis in the insertion vein

    7. Number of patients with device malfunctions [From CVC insertion until CVC withdrawal]

      Any device malfunction or technical problems during insertion, withdrawal or use

    8. 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

    9. Number of patients with adverse events [From CVC insertion until CVC withdrawal]

      including casuality assessment to the CVC use; both serious and non-serious

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danderyd Sjukhus Stockholm Sweden 18288

    Sponsors and Collaborators

    • Bactiguard AB
    • Danderyd Hospital

    Investigators

    • Principal Investigator: Jan Jakobsson, Prof, Danderyd Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bactiguard AB
    ClinicalTrials.gov Identifier:
    NCT03976557
    Other Study ID Numbers:
    • PL-13732
    First Posted:
    Jun 6, 2019
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bacteremia
    Catheter-Related Infections
    Thrombosis

    Study Results

    No Results Posted as of Jan 22, 2021