Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-04 @ 4:20 PM
Study NCT ID:
NCT03282292
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Co-PI responsible for study procedures moved to another hospital', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CVC colonization', 'timeFrame': '14 days', 'description': 'CVC positive culture after removal'}, {'measure': 'CRBSI', 'timeFrame': '14 days', 'description': 'Positive CVC culture and blood stream infection for the same organism'}, {'measure': 'CLABSI', 'timeFrame': 'More than 48 hours', 'description': 'A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.'}], 'secondaryOutcomes': [{'measure': 'Mechanical complications', 'timeFrame': '1 day', 'description': 'Defined as arterial puncture; hemothorax; pneumothorax'}, {'measure': 'Procedural difficulty', 'timeFrame': '1 hour', 'description': 'Defined by number of attempts; no guidewire progress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Line-associated Bloodstream Infection (CLABSI)', 'Central Venous Catheter Associated Bloodstream Infection', 'Heart; Surgery, Heart, Functional Disturbance as Result', 'Congenital Heart Disease', 'Newborn; Infection']}, 'referencesModule': {'references': [{'pmid': '3379183', 'type': 'RESULT', 'citation': 'Collignon P, Soni N, Pearson I, Sorrell T, Woods P. Sepsis associated with central vein catheters in critically ill patients. Intensive Care Med. 1988;14(3):227-31. doi: 10.1007/BF00717995.'}, {'pmid': '8870910', 'type': 'RESULT', 'citation': 'Pearson ML. Guideline for prevention of intravascular device-related infections. Part I. Intravascular device-related infections: an overview. The Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996 Aug;24(4):262-77. doi: 10.1016/s0196-6553(96)90058-9. No abstract available.'}, {'pmid': '15857534', 'type': 'RESULT', 'citation': 'de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.'}, {'pmid': '17875082', 'type': 'RESULT', 'citation': 'Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.'}, {'pmid': '12797890', 'type': 'RESULT', 'citation': 'Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.'}, {'pmid': '10362409', 'type': 'RESULT', 'citation': 'Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System. Crit Care Med. 1999 May;27(5):887-92. doi: 10.1097/00003246-199905000-00020.'}, {'pmid': '2921683', 'type': 'RESULT', 'citation': 'Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.'}, {'pmid': '28471906', 'type': 'RESULT', 'citation': 'He C, Vieira R, Marin JR. Utility of Ultrasound Guidance for Central Venous Access in Children. Pediatr Emerg Care. 2017 May;33(5):359-362. doi: 10.1097/PEC.0000000000001124.'}, {'pmid': '28585784', 'type': 'RESULT', 'citation': 'Sanchez Sanchez A, Giron Vallejo O, Ruiz-Pruneda R, Fernandez Ibieta M, Reyes Rios PY, Villamil V, Martinez-Castano I, Rojas Ticona J, Gimenez Aleixandre MC, Ruiz Jimenez JI. [Use of ultrasound for placement of central venous catheters in pediatrics: results of a national survey]. Cir Pediatr. 2017 Jan 25;30(1):9-16. Spanish.'}, {'pmid': '29941012', 'type': 'DERIVED', 'citation': 'Silvetti S, Aloisio T, Cazzaniga A, Ranucci M. Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):329. doi: 10.1186/s13063-018-2717-1.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.', 'detailedDescription': 'Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher risk of colonization and central-line associated bloodstream infection (CLABSI) than other sites (jugular or subclavian). In pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and CLABSI related to the insertion site. The experimental hypothesis of this randomized controlled trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization and CLABSI than the femoral site.\n\nMethods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC insertion will be performed by one out of three selected expert operators.\n\nThe primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection.\n\nSecondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPlanned cardiac surgery Age \\<1 year Eligibility for both insertion sites (jugular and femoral) for CVC Availability of at least one out of the three chosen expert operators\n\nExclusion Criteria:\n\nEmergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6 months No expert operator availability Intensive Care unit before surgery Central venous catheter inside at the time of randomization\n\nWithdraw criteria (only for the first endpoint):\n\nImpossibility to placement catheter in the selected site.'}, 'identificationModule': {'nctId': 'NCT03282292', 'acronym': 'PRECiSE', 'briefTitle': 'Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': 'PedCVC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jugular', 'description': 'CVC insertion in the left or right internal jugular vein', 'interventionNames': ['Procedure: Internal jugular vein CVC insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral', 'description': 'CVC insertion in the right or left femoral vein', 'interventionNames': ['Procedure: Internal jugular vein CVC insertion']}], 'interventions': [{'name': 'Internal jugular vein CVC insertion', 'type': 'PROCEDURE', 'description': 'Double lumen CVC insertion in the internal jugular vein', 'armGroupLabels': ['Femoral', 'Jugular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Policlinico S.Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'Marco Ranucci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Policlinico S. Donato'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'November 2017 - November 2020', 'ipdSharing': 'YES', 'description': 'The dataset will be made available at reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Clinical Research', 'investigatorFullName': 'Marco Ranucci', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}