Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-03 @ 9:21 AM
Study NCT ID:
NCT03457259
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Efficacy of Midline Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 patients in each group, with a total of 2 groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reducing the use of CVC and PVC', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.'}], 'secondaryOutcomes': [{'measure': 'Bloodsamples from catheter', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Registration of number of blood samples taken from the midline catheter'}, {'measure': 'Problems with catheter bloodsampling', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Registration of aspiration problems during bloodsampling in midline catheters'}, {'measure': 'Bloodsamples (conventional)', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Registration of number of blood samples taken from conventional blood samples in both groups'}, {'measure': 'Patient satisfaction', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied'}, {'measure': 'Nurse satisfaction', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied'}, {'measure': 'Painscore', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain'}, {'measure': 'Rescue catherizations 1', 'timeFrame': 'through study completion, an average of 7 month', 'description': "Rescue PVC's inserted (midline group) (no)"}, {'measure': 'Rescue catherizations 2', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Rescue central venous catheters including PICC line catheters inserted (no)'}, {'measure': 'Time consumption', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Total time of cauterization, (measured from the entrance in patient room, to the exit)'}, {'measure': 'Catheter dwelltime', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Time of catheter duration (hours)'}, {'measure': 'Fluid', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Accumulated fluids infused (L)'}, {'measure': 'Treatment type', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Type of medicine infused (all types)'}, {'measure': 'Treatment amount', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Amount of medicine infused (L)'}, {'measure': 'Catheter related infections', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Catheters removed due to suspected catheter-related infection (no)'}, {'measure': 'Thrombosis 1', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Thrombi visible at the catheter tip (no)'}, {'measure': 'Thrombosis 2', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Deep venous thrombosis of the ipsilateral arm (no)'}, {'measure': 'Thrombosis 3', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Superficial venous thrombosis of the ipsilateral arm (midline group) (no)'}, {'measure': 'Thrombosis 4', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)'}, {'measure': 'Catheter discontinuation', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Reasons for replacing catheters (all types)'}, {'measure': 'Insertion complication', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Arterial punctures during catheter insertions (no)'}, {'measure': 'Insertion complication 2', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'haematomas during catheter insertions (no)'}, {'measure': 'Insertion complication 3', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Misplaced catheters (no)'}, {'measure': 'Neuropraxia', 'timeFrame': 'through study completion, an average of 7 month', 'description': 'Post-procedure median nerve palsy/neuropraxia (midline group) (no)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midline catheter, peripheral venous catheter, central venous catheter, complication rate'], 'conditions': ['Intravenous Catheters']}, 'referencesModule': {'references': [{'pmid': '36507736', 'type': 'DERIVED', 'citation': 'Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to the Department of Infectious Disease or Department of Heart Disease.\n* ≥18 years of age\n* Expected requirement for iv. therapy \\>5 days from the day of enrolment as evaluated by a specialist in infectious diseases.\n* Mentally competency\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening\n* Personnel for insertion of midline catheter not available'}, 'identificationModule': {'nctId': 'NCT03457259', 'briefTitle': 'The Clinical Efficacy of Midline Catheters', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'midlineivauh18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midline', 'description': 'Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.', 'interventionNames': ['Device: Midline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.', 'interventionNames': ['Device: PVC and/or PICCline']}], 'interventions': [{'name': 'PVC and/or PICCline', 'type': 'DEVICE', 'otherNames': ['Conventional catheterization'], 'description': 'Pt. will receive PVC and/or PICCline', 'armGroupLabels': ['Conventional']}, {'name': 'Midline', 'type': 'DEVICE', 'otherNames': ['Powerglide'], 'description': 'Pt. will receive midline', 'armGroupLabels': ['Midline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology and Intensive Care East Section, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Emma Bundgaard, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical student, Research student', 'investigatorFullName': 'Emma Bundgaard Nielsen', 'investigatorAffiliation': 'University of Aarhus'}}}}