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

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ClinicalTrials.gov Identifier: NCT03976557
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Danderyd Hospital
Information provided by (Responsible Party):
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)


Condition or disease Intervention/treatment Phase
Vascular Access Complication Catheter-Related Infections Catheter Thrombosis Catheter Blockage Catheter Complications Catheter Site Discomfort Catheter Bacteraemia Device: BIP CVC Device: Standard CVC Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot, 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 : April 17, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIP CVC
Polyurethane CVC with noble metal coating
Device: BIP CVC
Central venous access with noble metal coated CVC
Other Name: Noble metal coated CVC

Active Comparator: Standard CVC
Standard CVC made of polyurethane
Device: Standard CVC
Central venous access with standard uncoated CVC
Other Name: Uncoated CVC




Primary Outcome Measures :
  1. Number of patients with catheter related complications [ Time Frame: From CVC insertion until CVC withdrawal ]
    Patients having any complication specified as secondary endpoints


Secondary Outcome Measures :
  1. Number of patients with CRBSI [ Time Frame: From CVC insertion until CVC withdrawal ]
    CRBSI - Catheter Related Blood Stream Infections

  2. Number of patients with CRI [ Time Frame: From CVC insertion until CVC withdrawal ]
    CRI - Catheter Related Infections

  3. Number of patients with local CVC infections [ Time Frame: 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 [ Time Frame: From CVC insertion until CVC withdrawal ]
    Reported as incidence

  5. Number of patients with stop or slower flow in any CVC lumen [ Time Frame: 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 [ Time Frame: From CVC insertion until CVC withdrawal ]
    Local thrombosis - thrombosis in the insertion vein

  7. Number of patients with device malfunctions [ Time Frame: 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 [ Time Frame: From CVC insertion until CVC withdrawal ]
    including the reason of use and dose / number of days

  9. Number of patients with adverse events [ Time Frame: From CVC insertion until CVC withdrawal ]
    including casuality assessment to the CVC use; both serious and non-serious



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976557


Contacts
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Contact: Dorota Johansson, PhD 46 70 6543171 dorota.johansson@bactiguard.se
Contact: Ylva Kai-Larsen, PhD 46 73 511 04 11 ylva.kai-larsen@bactiguard.se

Locations
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Sweden
Danderyd Sjukhus Recruiting
Stockholm, Sweden, 18288
Sponsors and Collaborators
Bactiguard AB
Danderyd Hospital
Investigators
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Principal Investigator: Jan Jakobsson, Prof Danderyd Hospital

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Responsible Party: Bactiguard AB
ClinicalTrials.gov Identifier: NCT03976557     History of Changes
Other Study ID Numbers: PL-13732
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Bacteremia
Catheter-Related Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes