Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-28 @ 11:54 PM
Study NCT ID:
NCT00680459
Status:
TERMINATED
Last Update Posted:
2014-03-12
First Post:
2008-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ethanol Locks for the Treatment of Central Venous Line Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D000925', 'term': 'Anticoagulants'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christine.McKiernan@bhs.org', 'phone': '413-794-5370', 'title': 'Dr. Christine McKiernan', 'organization': 'Baystate Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clearance of Central Venous Line Infection by Day 6 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'OG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 days', 'unitOfMeasure': 'number of CVL cleared', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'OG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '35 days', 'unitOfMeasure': 'number of lines preserved', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrence of Central Venous Line Infection Within 35 Days of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'OG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '35 days', 'unitOfMeasure': '# of pts with recurrent infection', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'FG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '70% Ethanol Solution', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'BG001', 'title': 'Heparin Flush', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '4.96', 'groupId': 'BG000'}, {'value': '6.33', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'inability to enroll adequate number of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2008-05-16', 'resultsFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-29', 'studyFirstPostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of Central Venous Line Infection by Day 6 of Study', 'timeFrame': '6 days'}], 'secondaryOutcomes': [{'measure': 'Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study', 'timeFrame': '35 days'}, {'measure': 'Recurrence of Central Venous Line Infection Within 35 Days of Enrollment', 'timeFrame': '35 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['central line infection', '70% ethanol', 'Sepsis'], 'conditions': ['Bloodstream Infection']}, 'referencesModule': {'references': [{'pmid': '17018464', 'type': 'BACKGROUND', 'citation': 'Onland W, Shin CE, Fustar S, Rushing T, Wong WY. Ethanol-lock technique for persistent bacteremia of long-term intravascular devices in pediatric patients. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1049-53. doi: 10.1001/archpedi.160.10.1049.'}]}, 'descriptionModule': {'briefSummary': "Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections\n\nPurpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections\n\nStudy Design Randomized Controlled Trial\n\nStudy Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution.\n\nOutcome Measures Treatment success as defined by-\n\n* Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment)\n* Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections\n\nTreatment failure as defined by-\n\n* Clinical worsening during treatment\n* Removal of the line due to persistent infection or sepsis\n* Recurrence of infection with the same pathogen within 30 days", 'detailedDescription': 'Ethanol Lock Technique Protocol (adapted from the Children\'s Hospital Los Angeles)\n\n1. Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 10. Treating physician and nurses will be blinded to patient group assignment. Syringes will be labeled "70% ethanol/heparin lock Study Solution"\n2. Cleanse Hands\n3. Use aseptic Technique throughout procedure\n4. Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry\n5. Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter\n6. Instill ethanol/heparin lock into the catheter to fill volume\n\n * Broviac Single Lumen 4.2 Fr (ID 0.7) Dose 0.8ml\n * Broviac Single Lumen 6.6 Fr (ID 1mm) Dose 0.8ml\n * Med-comp Single Lumen Catheter Dose 1.2ml\n * Hickman Double Lumen 7 Fr Distal (ID 1mm) Dose 1.2ml\n * Hickman Double Lumen 9 Fr Proximal (ID 0.7) Dose 1.2ml\n * Med-comp Double Lumen 8 or 10 Fr Dose 1.2ml\n * Port-a-cath- Any Port (including priming tubing) Dose 1.9ml\n7. Clamp the catheter\n8. Label the locked lumen with the provided label so that med is not flushed through the catheter\n9. Let ethanol dwell in catheter continuously for 4 hours\n10. When ethanol has dwelled for 4 hours, withdraw and discard the lock solution\n11. The above procedure should be repeated daily for 5 consecutive days\n12. The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 6 months-23 years\n* documented central line infection with bacteria or fungus (positive blood culture)\n\nExclusion Criteria:\n\n* allergy or intolerance to ethanol\n* pregnant or breastfeeding\n* central line tunnel or exit site infection'}, 'identificationModule': {'nctId': 'NCT00680459', 'briefTitle': 'Ethanol Locks for the Treatment of Central Venous Line Infections', 'organization': {'class': 'OTHER', 'fullName': 'Baystate Medical Center'}, 'officialTitle': 'Ethanol Locks for the Treatment of Central Venous Line Infections', 'orgStudyIdInfo': {'id': 'IRB08-064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'interventionNames': ['Drug: 70% ethanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'interventionNames': ['Drug: heparin flush solution']}], 'interventions': [{'name': '70% ethanol', 'type': 'DRUG', 'otherNames': ['alcohol'], 'description': '70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'armGroupLabels': ['1']}, {'name': 'heparin flush solution', 'type': 'DRUG', 'otherNames': ['anticoagulant'], 'description': 'heparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Christine A McKiernan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baystate Medical Center'}, {'name': 'Amanda Conti, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baystate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baystate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Chief, Pediatric Critical Care', 'investigatorFullName': 'christine mckiernan', 'investigatorAffiliation': 'Baystate Medical Center'}}}}