Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT01405534
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2011-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1780}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the acute complications rate', 'timeFrame': 'From day 1 to day 7', 'description': 'Placement of the central venous catheter on day 1 and follow-up of potential acute complications'}], 'secondaryOutcomes': [{'measure': 'Assess the preoperative anxiety', 'timeFrame': 'On day 1', 'description': 'By means of Beck anxiety inventory'}, {'measure': 'Assess patients satisfaction about the catheter', 'timeFrame': 'On day 7', 'description': 'By means of a questionnary filled in by patients at home'}, {'measure': 'Assess postoperative pain', 'timeFrame': 'On day 1 and on day 7', 'description': 'The pain will be assessed on day 1 by a visual analogic scale and on day 7 by a verbal numeric scale'}, {'measure': 'Assess the rate of late complications', 'timeFrame': 'Up to 1 year', 'description': 'The anaesthesia staff will keep patients under surveillance for potential late complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheterization, Central Venous'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '16596560', 'type': 'BACKGROUND', 'citation': 'Gambotti L, Perol D, Frering B, Kaemmerlen P, Coronel B, Sebban H, Bulso V, Bachelot V, Chauvin F, Bachmann P. Safety of percutaneous internal jugular catheterization in cancer patients: prospective observational study. J Vasc Access. 2004 Oct-Dec;5(4):161-7. doi: 10.1177/112972980400500405.'}, {'pmid': '16970212', 'type': 'BACKGROUND', 'citation': 'Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.'}, {'pmid': '19851535', 'type': 'BACKGROUND', 'citation': 'Burns KE, McLaren A. Catheter-related right atrial thrombus and pulmonary embolism: a case report and systematic review of the literature. Can Respir J. 2009 Sep-Oct;16(5):163-5. doi: 10.1155/2009/751507.'}, {'pmid': '21165289', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Park HS, Hong DS. Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study. J Korean Med Sci. 2010 Dec;25(12):1748-53. doi: 10.3346/jkms.2010.25.12.1748. Epub 2010 Nov 24.'}, {'pmid': '21368740', 'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.'}, {'pmid': '20513216', 'type': 'BACKGROUND', 'citation': "Yacopetti N, Alexandrou E, Spencer TR, Frost SA, Davidson PM, O'Sullivan G, Hillman KM. Central venous catheter insertion by a clinical nurse consultant or anaesthetic medical staff: a single-centre observational study. Crit Care Resusc. 2010 Jun;12(2):90-5."}]}, 'descriptionModule': {'briefSummary': 'It is an observational, prospective, monocentric study. The purpose of the study is to assess the acute complications rate caused by a central venous catheter placement.\n\nAll the patients who require a central venous placement could be enrolled in the study.\n\nThe study will not change the usual practice. The placement will be on day 1 and patients will be contacted by phone on day 7 to identify potential complications and to assess pain.\n\nAnaesthesia staff will keep patients under surveillance to control the absence of late complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patient who require the placement of a central venous catheter', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18.\n* Patient who requires the placement of a central venous catheter (a portacath (PAC), a peripherally inserted central catheter (PICC) or a tunnelled catheter).\n* Patient able to understand, read and write French.\n* Mandatory affiliation with a health insurance system.\n\nExclusion Criteria:\n\n* Active infection at placement of the central venous catheter.\n* Patient who can't be contacted by phone.\n* Patient who is likely to have a femoral venous catheter placement."}, 'identificationModule': {'nctId': 'NCT01405534', 'acronym': 'VVC', 'briefTitle': 'Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study', 'orgStudyIdInfo': {'id': 'VVC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Central venous catheter', 'description': 'All patients who require the placement of a central venous catheter'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Hervé ROSAY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}