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Trial record 1 of 1 for:    NCT02134769
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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.
 
ClinicalTrials.gov Identifier: NCT02134769
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Vygon GmbH & Co. KG
Information provided by (Responsible Party):
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date November 15, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Incidence of catheter-related bloodstream infections using Bionecteurs [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02134769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Length of Stay in ICU [ Time Frame: 1 year ]
Determine days in ICU with centrral venous catheter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Bionecteurs on Catheter-associated Infection
Official Title  ICMJE Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Infection
Intervention  ICMJE Device: Bionecteur
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Other Name: bionector® company: Vygon
Study Arms  ICMJE
  • No Intervention: Control
    No use of Bionecteur; handling according to institutional guideline
  • Active Comparator: Bionecteur
    Use of Bionecteur; handling according to institutional guideline
    Intervention: Device: Bionecteur
Publications * Koeppen M, Weinert F, Oehlschlaeger S, Koerner A, Rosenberger P, Haeberle HA. Needle-free connectors catheter-related bloodstream infections: a prospective randomized controlled trial. Intensive Care Med Exp. 2019 Dec 2;7(1):63. doi: 10.1186/s40635-019-0277-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2016)
221
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
200
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134769
Other Study ID Numbers  ICMJE BIONECT-2014
ZVK-Bionect ( Other Identifier: University Hospital Tuebingen )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Vygon GmbH & Co. KG
Investigators  ICMJE
Principal Investigator: Helene A Haeberle, MD University Hospital Tuebingen, Germany
PRS Account University Hospital Tuebingen
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP