Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-17 @ 5:03 PM
Study NCT ID:
NCT02538159
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2015-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D014115', 'term': 'Toxemia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Bacteraemia', 'timeFrame': '30 days', 'description': 'Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter'}], 'secondaryOutcomes': [{'measure': 'morbidities in catheter insertion', 'timeFrame': '1 day', 'description': 'Number of participants with complications during catheter insertion'}, {'measure': 'Comparison of morbidities during manipulation of the catheters', 'timeFrame': '30 days', 'description': 'Number of participants with complications during manipulation of the catheters'}, {'measure': '30 days Mortality', 'timeFrame': '30 days', 'description': 'Number of died participants'}, {'measure': 'Visual analogic scale of Pain', 'timeFrame': '30 days', 'description': 'Visual analogic scale of Pain in site of insertion from insertion until remove of the catheter'}, {'measure': 'Health-care costs', 'timeFrame': '30 days', 'description': 'Economic study of the whole procedure including complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-tunneled Central venous catheter', 'Bacteraemia', 'Peripherally inserted central venous catheter'], 'conditions': ['Catheter Related Infections']}, 'descriptionModule': {'briefSummary': 'Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ≥ 18 years.\n* Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital.\n* Signed informed consent by the patient and / or when necessary parent / legal guardian.\n\nExclusion Criteria:\n\n* Patients with bacteremia at the time of catheter insertion.\n* Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients.\n* Patients with severe clinical situation.\n* Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient.\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT02538159', 'acronym': 'PYCBAC', 'briefTitle': 'Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Randomized, Prospective, Single-center Study to Compare the Effectiveness and Safety in Terms of Catheter Bacteraemia, Between Peripherally Inserted Central Catheters and Non-tunneled Central Venous Catheter in Tertiary Hospital', 'orgStudyIdInfo': {'id': 'IIBSP-CAT-2014-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental CVC', 'description': 'CVC insertion Non-tunneled Central venous catheter insertion', 'interventionNames': ['Device: CVC']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental PICC', 'description': 'PICC insertion Peripherally inserted catheter', 'interventionNames': ['Device: PICC']}], 'interventions': [{'name': 'CVC', 'type': 'DEVICE', 'description': 'The inclusion of any CVC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. In the case of CVC, the subclavian vein of choice will be followed by the femoral and jugular. Seldinger technique with direct radiation control in the operating room is used.', 'armGroupLabels': ['Experimental CVC']}, {'name': 'PICC', 'type': 'DEVICE', 'description': 'The inclusion of any PICC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. PICC vein of choice is the basilica vein with help of Ecography in the interventional radiology room.', 'armGroupLabels': ['Experimental PICC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}