Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 6:54 PM
Study NCT ID:
NCT00757458
Status:
UNKNOWN
Last Update Posted:
2008-09-23
First Post:
2008-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004492', 'term': 'Edetic Acid'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 652}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-22', 'studyFirstSubmitDate': '2008-09-22', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Propofol', 'Bacterial growth', 'Fungal growth', 'EDTA', 'Target controlled infusion'], 'conditions': ['Drug Contamination']}, 'referencesModule': {'references': [{'pmid': '16802492', 'type': 'BACKGROUND', 'citation': 'Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. doi: 10.1177/0310057X0603400305.'}, {'pmid': '17506735', 'type': 'BACKGROUND', 'citation': 'Fukada T, Ozaki M. Microbial growth in propofol formulations with disodium edetate and the influence of venous access system dead space. Anaesthesia. 2007 Jun;62(6):575-80. doi: 10.1111/j.1365-2044.2007.05002.x.'}, {'pmid': '12826541', 'type': 'BACKGROUND', 'citation': 'Trepanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. doi: 10.1007/BF03018635. No abstract available. English, French.'}, {'pmid': '7791816', 'type': 'BACKGROUND', 'citation': 'Bennett SN, McNeil MM, Bland LA, Arduino MJ, Villarino ME, Perrotta DM, Burwen DR, Welbel SF, Pegues DA, Stroud L, et al. Postoperative infections traced to contamination of an intravenous anesthetic, propofol. N Engl J Med. 1995 Jul 20;333(3):147-54. doi: 10.1056/NEJM199507203330303.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the existence of bacterial and/or fungal contamination during different technics of propofol with or without EDTA continuous infusion in patients undergoing general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age eighteen years old or more\n* ASA Physiological Status P1 ou P2\n* Patients undergoing clean procedure under general anesthesia.\n\nExclusion Criteria:\n\n* Patients under eighteen years old\n* ASA Physiological Status P3, P4 or P5\n* Current infectious process'}, 'identificationModule': {'nctId': 'NCT00757458', 'briefTitle': 'Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'EDTA-652'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'TCI with EDTA', 'interventionNames': ['Drug: EDTA without re-filling']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA', 'interventionNames': ['Other: Propofol syringe re-filling with propofol containing EDTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA', 'interventionNames': ['Other: Re-filling of syringe with propofol without EDTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Target controlled infusion of propofol without EDTA', 'interventionNames': ['Other: Target controlled infusion of propofol without EDTA']}], 'interventions': [{'name': 'EDTA without re-filling', 'type': 'DRUG', 'description': 'Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.', 'armGroupLabels': ['1']}, {'name': 'Propofol syringe re-filling with propofol containing EDTA', 'type': 'OTHER', 'description': 'Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.', 'armGroupLabels': ['2']}, {'name': 'Target controlled infusion of propofol without EDTA', 'type': 'OTHER', 'description': 'Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment', 'armGroupLabels': ['4']}, {'name': 'Re-filling of syringe with propofol without EDTA', 'type': 'OTHER', 'description': 'Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de Sao Paulo Hospital das Clinicas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Maria Jose C Carmona, Professor', 'role': 'CONTACT', 'email': 'maria.carmona@incor.usp.br', 'phone': '55-11-3069-5367'}, {'name': 'Jose Otavio C Auler Jr, Full Professor', 'role': 'CONTACT', 'email': 'auler@hcnet.usp.br', 'phone': '55-11-3069-5232'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jose Otavio Costa Auler Jr. / Full Professor Department of Anesthesiology', 'oldOrganization': 'Universidade de Sao Paulo'}}}}