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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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring catheter-related bloodstream infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 9, 2014
Last Updated
November 11, 2016
Sponsor
University Hospital Tuebingen
Collaborators
Vygon GmbH & Co. KG
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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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