Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT02134769
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2014-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Bionecteurs on Catheter-associated Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-11', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-05-07', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of catheter-related bloodstream infections using Bionecteurs', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Length of Stay in ICU', 'timeFrame': '1 year', 'description': 'Determine days in ICU with centrral venous catheter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['catheter-related bloodstream infections'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '31792889', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '* Prospective, randomised observational study\n* Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) \\> 3 days\n\n * Inclusion:\n\n \\---- Age ≥ 18 years\n\n ---. demand of central venous and arterial line\n\n \\--- written consent of patient and/or assignee\n * Exclusion\n\n * Handicapped patients\n * patient with ICU LOS \\< 3 days\n* Study design\n\n 1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection\n 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.\n 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.\n 4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment\n 5. The study will be finished ab discharge of ICU or removal of catheters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Length of Stay (LOS) in ICU \\> 3 days\n* written consent by patient or notarial carers\n* medical indication for central venous line/arterial line\n\nExclusion Criteria:\n\n* handicap\n* LOS ICU \\< 3 days\n* no consent'}, 'identificationModule': {'nctId': 'NCT02134769', 'acronym': 'Bionect', 'briefTitle': 'Influence of Bionecteurs on Catheter-associated Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device', 'orgStudyIdInfo': {'id': 'BIONECT-2014'}, 'secondaryIdInfos': [{'id': 'ZVK-Bionect', 'type': 'OTHER', 'domain': 'University Hospital Tuebingen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No use of Bionecteur; handling according to institutional guideline'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bionecteur', 'description': 'Use of Bionecteur; handling according to institutional guideline', 'interventionNames': ['Device: Bionecteur']}], 'interventions': [{'name': 'Bionecteur', 'type': 'DEVICE', 'otherNames': ['bionector® company: Vygon'], 'description': 'Using Bionecteur at each lumina of the catheter; handling according to institutional guideline', 'armGroupLabels': ['Bionecteur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Helene A Haeberle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vygon GmbH & Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}