Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-02 @ 3:06 PM
Study NCT ID:
NCT00571259
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2007-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Antimicrobial Catheter Lock
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D006493', 'term': 'Heparin'}, {'id': 'D000077559', 'term': 'Sodium Citrate'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leggv@satellitehealth.com', 'phone': '360-607-6892', 'title': 'Veronica Legg, MS: Director of Research Business', 'organization': 'Satellite Healthcare, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The requirement for dialysis facility staff to prepare the treatment intervention prevented a completely blinded study.'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': '1: Heparin Lock', 'description': 'Dialysis Catheter locked with heparin 1,000 units/mL.\n\nHeparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'deathsNumAffected': 25, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': '2: Gentamicin Lock', 'description': 'Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.\n\n4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 0, 'seriousNumAtRisk': 155, 'deathsNumAffected': 27, 'seriousNumAffected': 27}], 'seriousEvents': [{'term': 'ESRD Related Death', 'notes': "Serious adverse events were deaths of dialysis subjects which were related to ESRD or the subject's comorbid conditions, not study related.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Device-related Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1: Heparin Lock', 'description': 'Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.\n\nHeparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}, {'id': 'OG001', 'title': '2: Gentamicin Lock', 'description': 'Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.\n\n4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection', 'unitOfMeasure': 'Number of infections', 'reportingStatus': 'POSTED', 'populationDescription': 'Episodes of catheter related infections in each group throughout the study.'}, {'type': 'SECONDARY', 'title': 'Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1: Heparin Lock', 'description': 'Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.'}, {'id': 'OG001', 'title': '2: Gentamicin Lock', 'description': 'Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.42', 'groupId': 'OG000'}, {'value': '2.36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting.', 'unitOfMeasure': 'tPA use/1,000 catheter-days', 'reportingStatus': 'POSTED', 'populationDescription': 'tPA use/1,000 catheter-days'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1: Heparin Lock', 'description': 'Dialysis Catheter locked with heparin 1,000 units/mL.\n\nHeparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}, {'id': 'FG001', 'title': '2: Gentamicin Lock', 'description': 'Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.\n\n4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '141'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1: Heparin Lock', 'description': 'Dialysis catheter locked with heparin 1,000 units/mL post-dialysis.\n\nHeparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}, {'id': 'BG001', 'title': '2: Gentamicin Lock', 'description': 'Dialysis catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% post-dialysis.\n\n4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '14.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Percent of subjects in each cohort who were diabetic.', 'unitOfMeasure': 'Participants'}, {'title': 'Dialysis vintage in Months', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '131.8'}, {'value': '42.4', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '198.5'}, {'value': '43.32', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '198.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The number of months the subject has been on hemodialysis.', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Incident Catheters', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Catheter site', 'classes': [{'categories': [{'title': 'Internal Jugular', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'External Jugular', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Femoral', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Subclavian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All adult patients with either newly placed or existing tunneled cuffed catheters were eligible for enrollment. Patients were excluded if they had an active exit-site or tunnel infection or other systemic or localized infection that was unresponsive to antibiotic therapy and/or was life-threatening. Eligible patients were randomly assigned 1:1 to treatment or control groups.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2007-12-10', 'resultsFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-21', 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Device-related Bacteremia', 'timeFrame': '5 years', 'description': 'Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection'}], 'secondaryOutcomes': [{'measure': 'Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow', 'timeFrame': '5 years', 'description': 'The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sodium citrate', 'Gentamicin', 'Prophylaxis', 'Hemodialysis', 'Central venous catheter'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.', 'detailedDescription': 'The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.\n* Must be at least 18 years old\n* Compliant with a dialysis treatment schedule\n* Plans to continue hemodialysis treatment and follow-up at the investigational site\n* Must be able to care for the exit site independently or have someone who is able to care for the site for them\n* Must be able to sign the informed consent document\n\nExclusion Criteria:\n\n* The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred\n* Active exit site or tunnel infection\n* Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening\n* Known to have antibodies to heparin\n* Allergy to pork heparin\n* Allergy to gentamicin\n* Subject is pregnant\n* Known intravenous drug abuse'}, 'identificationModule': {'nctId': 'NCT00571259', 'acronym': 'ALLOCK', 'briefTitle': 'Prophylactic Antimicrobial Catheter Lock', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SR001AL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Catheter lock with heparin 1,000 units/mL', 'interventionNames': ['Drug: Heparin 1000U/mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%', 'interventionNames': ['Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL']}], 'interventions': [{'name': 'Heparin 1000U/mL', 'type': 'DRUG', 'description': 'A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis', 'armGroupLabels': ['1']}, {'name': '4% Sodium Citrate with Gentamicin 320 mcg/mL', 'type': 'DRUG', 'description': 'A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94041', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare, Inc', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Norman Coplon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}