Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-07 @ 5:39 AM
Study NCT ID:
NCT01947751
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2013-09-18', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection resolution', 'timeFrame': '4 weeks', 'description': 'Compare the resolution of CVC-related infection between the group that had the CVC exchanged, versus the CVC-maintenance plus adding antibiotics therapy group.'}], 'secondaryOutcomes': [{'measure': 'Clinical variables', 'timeFrame': '6 months', 'description': 'Comparison of PCR, leukocytes, temperature, length of stay and mortality in the two groups, as well as complication rates and number of catheters removed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheter related infection', 'Central venous catheter', 'CVC infection'], 'conditions': ['Catheter Related Infection']}, 'descriptionModule': {'briefSummary': 'Central venous catheter(CVC)-related infection is an inherent complication of this device that should be treated promptly. However, there are doubts about the need for the immediate withdrawal of CVC while there is still no confirmation of such infection. The aim of this study is to compare the resolution of CVC-related infection, testing two approaches: catheter´s early exchange, when the possibility of related sepsis is considered, versus the maintenance of the CVC and early antibiotic therapy until the infection is confirmed.', 'detailedDescription': 'The aim of this study is to compare the strategy of immediate removal of the catheter with a conservative strategy in resolution of infection in patients with sepsis or septic shock without a defined origin. The investigators intend to demonstrate that the conservative strategy can reduce the rate of unnecessary catheter removal, without increasing morbidity.\n\nIn the intervention group the investigators will adopt the conservative strategy, changing the CVC after the confirmation of infection related to it or non-improvement of sepsis. The control group is represented by the patients in whom the CVC is removed early.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with 18 years or more, admitted to ICU that had a CVC inserted before or after ICU admission and with infection with undefined origin.\n\nExclusion Criteria:\n\n* Less than 18 years, severe neutropenia (\\<500/mm³), intravascular device (pacemaker, prosthetic valve), unequivocal signs of infection on the site of CVC insertion, patients who were terminally ill defined, bacteremia without a known source, refusal to signing the informed consent.'}, 'identificationModule': {'nctId': 'NCT01947751', 'briefTitle': 'Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nossa Senhora da Conceicao'}, 'officialTitle': 'Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin', 'orgStudyIdInfo': {'id': 'HNSConceicao'}, 'secondaryIdInfos': [{'id': 'HNSC022014', 'type': 'REGISTRY', 'domain': '022014'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CVC exchange', 'description': 'The CVC will be removed immediately.', 'interventionNames': ['Procedure: CVC exchange']}, {'type': 'EXPERIMENTAL', 'label': 'CVC maintenance', 'description': 'The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis', 'interventionNames': ['Drug: CVC maintenance']}], 'interventions': [{'name': 'CVC exchange', 'type': 'PROCEDURE', 'description': 'CVC exchange when related infection is suspected', 'armGroupLabels': ['CVC exchange']}, {'name': 'CVC maintenance', 'type': 'DRUG', 'otherNames': ['Watchful waiting strategy'], 'description': 'CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC', 'armGroupLabels': ['CVC maintenance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcio M Boniatti, PhD', 'role': 'CONTACT', 'email': 'marciobt@terra.com.br', 'phone': '555133572221'}, {'name': 'Marcio M Boniatti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Nossa Senhora da Conceicao', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Marcio M Boniatti, PhD', 'role': 'CONTACT', 'email': 'marciobt@terra.com.br', 'phone': '555133572221'}], 'overallOfficials': [{'name': 'Marcio M Boniatti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nossa Senhora da Conceicao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Nossa Senhora da Conceicao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marcio Manozzo Boniatti', 'investigatorAffiliation': 'Hospital Nossa Senhora da Conceicao'}}}}