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Influence of Bionecteurs on Catheter-associated Infection (Bionect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134769
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : November 15, 2016
Vygon GmbH & Co. KG
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon. However, there are no studies describing a positive effect of using Bionecteurs ® in regard to catheter-related bloodstream infections. In this study Bionecteur® will be used on central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of catheter-related bloodstream infections will we compared to patients without inclusion of Bionecteur® devices.

Condition or disease Intervention/treatment Phase
Infection Device: Bionecteur Not Applicable

Detailed Description:
  • Prospective, randomised observational study
  • Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) > 3 days

    • Inclusion:

      ---- Age ≥ 18 years

      ---. demand of central venous and arterial line

      --- written consent of patient and/or assignee

    • Exclusion

      • Handicapped patients
      • patient with ICU LOS < 3 days
  • Study design

    1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
    2. Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
    3. Biconecteurs® are connected to all lumens of the central catheter and to arterial catheter. Control group is treated without using Bionecteurs®. Handling of vascular catheters are performed as described in institutional guidelines in both groups.
    4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
    5. The study will be finished ab discharge of ICU or removal of catheters.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
No Intervention: Control
No use of Bionecteur; handling according to institutional guideline
Active Comparator: Bionecteur
Use of Bionecteur; handling according to institutional guideline
Device: Bionecteur
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Other Name: bionector® company: Vygon

Primary Outcome Measures :
  1. Incidence of catheter-related bloodstream infections using Bionecteurs [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Length of Stay in ICU [ Time Frame: 1 year ]
    Determine days in ICU with centrral venous catheter

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Length of Stay (LOS) in ICU > 3 days
  • written consent by patient or notarial carers
  • medical indication for central venous line/arterial line

Exclusion Criteria:

  • handicap
  • LOS ICU < 3 days
  • no consent

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 identifier (NCT number): NCT02134769

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University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Vygon GmbH & Co. KG
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Principal Investigator: Helene A Haeberle, MD University Hospital Tuebingen, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen Identifier: NCT02134769    
Other Study ID Numbers: BIONECT-2014
ZVK-Bionect ( Other Identifier: University Hospital Tuebingen )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Tuebingen:
catheter-related bloodstream infections
Additional relevant MeSH terms:
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Communicable Diseases
Disease Attributes
Pathologic Processes