Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 7:37 PM
Study NCT ID:
NCT01229592
Status:
TERMINATED
Last Update Posted:
2012-07-17
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethanol in the Prevention of Central Venous Catheter Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-27', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catheter infectionrelated incidence rates', 'timeFrame': '2 years', 'description': 'decrease on catheter infection related incidence rates in comparison to the institution incidence figures'}], 'secondaryOutcomes': [{'measure': 'cathether bacteriaemia related rate', 'timeFrame': '2 years', 'description': 'versus Institution rate figures'}, {'measure': 'antimicrobial consume', 'timeFrame': '2 years', 'description': 'Defined Diary Dosis(DDDs)in both arms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infection', 'catheter', 'bacteriaemia', 'ethanol'], 'conditions': ['Catheter Related Infection']}, 'referencesModule': {'references': [{'pmid': '24675993', 'type': 'DERIVED', 'citation': 'Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success \\[1-10\\].\n\nLong-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.\n\nEthanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.\n\nObjectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).\n\nMethods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old\n* Signed informed consent\n* central Venous catheter more than 48 hours placed\n\nExclusion Criteria:\n\n* pregnancy\n* denial Informed consent Form\n* ethanol intolerance\n* Liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT01229592', 'briefTitle': 'Ethanol in the Prevention of Central Venous Catheter Infections', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections', 'orgStudyIdInfo': {'id': 'EC07/90653'}, 'secondaryIdInfos': [{'id': '2007-007063-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ethanol', 'description': 'Every three day lock using Ethanol in all the lumen of the Catheter', 'interventionNames': ['Drug: Ethanol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heparine', 'description': 'Every three day lock using Heparine in all the lumen of the Catheter', 'interventionNames': ['Drug: Heparine']}], 'interventions': [{'name': 'Ethanol', 'type': 'DRUG', 'description': 'Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter', 'armGroupLabels': ['Ethanol']}, {'name': 'Heparine', 'type': 'DRUG', 'description': 'Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter', 'armGroupLabels': ['Heparine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}