InfectionBionectNCT02134769
Influence of Bionecteurs on Catheter-associated Infection
A study testing Bionecteur in people with Infection, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Bionecteur
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Length of Stay (LOS) in ICU > 3 days
- written consent by patient or notarial carers
- medical indication for central venous line/arterial line
Who cannot join
- handicap
- LOS ICU < 3 days
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
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.
Read the 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.
- Conditions
- Infection
- Being tested
- Bionecteur
- Keywords
- catheter-related bloodstream infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BionecteurDevice
Also called bionector® company: Vygon
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No use of Bionecteur; handling according to institutional guideline |
| Bionecteur | Active comparator | Use of Bionecteur; handling according to institutional guideline Receives: Device: Bionecteur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related bloodstream infections using Bionecteurs
Measured: 1 year
Secondary outcomes (1)
Length of Stay in ICU
Determine days in ICU with centrral venous catheter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Helene A Haeberle, MD, Principal investigator, University Hospital Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134769
- Sponsor's protocol ID
- BIONECT-2014
- Other IDs
- ZVK-Bionect
- Acronym
- Bionect
- Status last verified
- Jul 2015
- First submitted
- 9 Apr 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 31792889
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
- ClinicalTrials.gov ID
- NCT02134769
- Acronym / sponsor ID
- Bionect / BIONECT-2014
- Conditions
- Infection
- Keywords
- catheter-related bloodstream infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No use of Bionecteur; handling according to institutional guideline |
| Bionecteur | Active comparator | Device: BionecteurUse of Bionecteur; handling according to institutional guideline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Length of Stay (LOS) in ICU > 3 days
- written consent by patient or notarial carers
- medical indication for central venous line/arterial line
Key exclusion criteria (3 listed)
- handicap
- LOS ICU < 3 days
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BionecteurAlso: bionector® company: VygonUsing Bionecteur at each lumina of the catheter; handling according to institutional guideline | Device | Bionecteur |
Primary outcome
Incidence of catheter-related bloodstream infections using Bionecteurs
Time frame: 1 year
1 secondary outcome
Length of Stay in ICU
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 31792889Koeppen 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.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene A Haeberle, MD principal investigator
University Hospital Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionecteur in people with Infection, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related bloodstream infections using Bionecteurs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.