Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-28 @ 2:18 PM
Study NCT ID:
NCT03908866
Status:
UNKNOWN
Last Update Posted:
2019-04-23
First Post:
2019-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002406', 'term': 'Catheterization, Peripheral'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2019-04-07', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thrombotic complications', 'timeFrame': 'up to 30 days or be discharged from hospital', 'description': 'radiographically-confirmed upper-extremity deep vein thrombosis'}, {'measure': 'mechanical complications', 'timeFrame': 'up to 30 days or be discharged from hospital', 'description': 'pneumothorax or hematoma caused by puncture'}, {'measure': 'infectious complications', 'timeFrame': 'up to 30 days or be discharged from hospital', 'description': 'catheter related bloodstream infection'}], 'secondaryOutcomes': [{'measure': 'catheter replacement', 'timeFrame': 'up to 30 days or be discharged from hospital', 'description': 'obstruction or accidental removal'}, {'measure': 'cost effectiveness', 'timeFrame': 'up to 30 days or be discharged from hospital', 'description': 'The cost of catheter implantation and replacement, as well as the cost of treatment due to catheter-related complications and the resulting financial loss to the patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thromboses, Venous', 'Infection', 'Economic Problems']}, 'descriptionModule': {'briefSummary': 'This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.\n\nExclusion Criteria:\n\n* Insertion of the central catheter in emergency situations;\n* Anatomical abnormalities of upper extremity affecting PICC placement;\n* Current or recent (within 1 month) diagnosis of bacteremia\n* Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;\n* Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;'}, 'identificationModule': {'nctId': 'NCT03908866', 'acronym': 'PICINI', 'briefTitle': 'Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety', 'orgStudyIdInfo': {'id': 'XJTU1AF2019LSK-2019-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PICC(Peripherally inserted central catheter)', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter(PICC).', 'interventionNames': ['Other: PICC(Peripherally inserted central catheter)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CVC(Central venous catheter )', 'description': 'Patients randomly assigned to receive a centrally inserted central venous catheter(CVC).', 'interventionNames': ['Other: CVC(Central venous catheter )']}], 'interventions': [{'name': 'PICC(Peripherally inserted central catheter)', 'type': 'OTHER', 'description': 'The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.', 'armGroupLabels': ['PICC(Peripherally inserted central catheter)']}, {'name': 'CVC(Central venous catheter )', 'type': 'OTHER', 'description': 'The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.', 'armGroupLabels': ['CVC(Central venous catheter )']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Liu, MD', 'role': 'CONTACT', 'email': 'hao_liu@xjtu.edu.cn', 'phone': '0086-029-85324005'}, {'name': 'Hao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Zhang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Hao Liu, MD', 'role': 'CONTACT', 'email': 'hao_liu@xjtu.edu.cn', 'phone': '0086-029-85324005'}], 'overallOfficials': [{'name': 'Hao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}