Influence of Bionecteurs on Catheter-associated Infection (Bionect)
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bionecteur
Sponsored by

About this trial
This is an interventional prevention trial for Infection focused on measuring catheter-related bloodstream infections
Eligibility Criteria
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
Sites / Locations
- University Hospital Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Bionecteur
Arm Description
No use of Bionecteur; handling according to institutional guideline
Use of Bionecteur; handling according to institutional guideline
Outcomes
Primary Outcome Measures
Incidence of catheter-related bloodstream infections using Bionecteurs
Secondary Outcome Measures
Length of Stay in ICU
Determine days in ICU with centrral venous catheter
Full Information
NCT ID
NCT02134769
First Posted
April 9, 2014
Last Updated
November 11, 2016
Sponsor
University Hospital Tuebingen
Collaborators
Vygon GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT02134769
Brief Title
Influence of Bionecteurs on Catheter-associated Infection
Acronym
Bionect
Official Title
Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Vygon GmbH & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
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.
Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
The study will be finished ab discharge of ICU or removal of catheters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
catheter-related bloodstream infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No use of Bionecteur; handling according to institutional guideline
Arm Title
Bionecteur
Arm Type
Active Comparator
Arm Description
Use of Bionecteur; handling according to institutional guideline
Intervention Type
Device
Intervention Name(s)
Bionecteur
Other Intervention Name(s)
bionector® company: Vygon
Intervention Description
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Primary Outcome Measure Information:
Title
Incidence of catheter-related bloodstream infections using Bionecteurs
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Length of Stay in ICU
Description
Determine days in ICU with centrral venous catheter
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene A Haeberle, MD
Organizational Affiliation
University Hospital Tuebingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31792889
Citation
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.
Results Reference
derived
Learn more about this trial
Influence of Bionecteurs on Catheter-associated Infection
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