Influence of Bionecteurs on Catheter-associated Infection
NCT ID: NCT02134769
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
221 participants
INTERVENTIONAL
2014-08-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No use of Bionecteur; handling according to institutional guideline
No interventions assigned to this group
Bionecteur
Use of Bionecteur; handling according to institutional guideline
Bionecteur
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bionecteur
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* written consent by patient or notarial carers
* medical indication for central venous line/arterial line
Exclusion Criteria
* LOS ICU \< 3 days
* no consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vygon GmbH & Co. KG
INDUSTRY
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helene A Haeberle, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Tuebingen
Tübingen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZVK-Bionect
Identifier Type: OTHER
Identifier Source: secondary_id
BIONECT-2014
Identifier Type: -
Identifier Source: org_study_id