Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT01665092
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2012-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rapid Administration of Carnitine in sEpsis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aejones@umc.edu', 'phone': '601-384-5586', 'title': 'Alan Jones', 'organization': 'Univeristy of Mississippi Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Normal saline\n\nplacebo', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carnitine Low', 'description': 'Levo-Carnitine 6g\n\nLevo-Carnitine', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Carnitine Medium', 'description': 'Levo-Carnitine 12 g\n\nLevo-Carnitine', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Carnitine High', 'description': 'Levo-Carnitine 18 g\n\nLevo-Carnitine', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 45, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delta SOFA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Normal saline\n\nplacebo'}, {'id': 'OG001', 'title': 'Carnitine Low', 'description': 'Levo-Carnitine 6g\n\nLevo-Carnitine'}, {'id': 'OG002', 'title': 'Carnitine Medium', 'description': 'Levo-Carnitine 12 g\n\nLevo-Carnitine'}, {'id': 'OG003', 'title': 'Carnitine High', 'description': 'Levo-Carnitine 18 g\n\nLevo-Carnitine'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '-1.68', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '0.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Normal saline\n\nplacebo'}, {'id': 'FG001', 'title': 'Carnitine Low', 'description': 'Levo-Carnitine 6g\n\nLevo-Carnitine'}, {'id': 'FG002', 'title': 'Carnitine Medium', 'description': 'Levo-Carnitine 12 g\n\nLevo-Carnitine'}, {'id': 'FG003', 'title': 'Carnitine High', 'description': 'Levo-Carnitine 18 g\n\nLevo-Carnitine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '250', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Normal saline\n\nplacebo'}, {'id': 'BG001', 'title': 'Carnitine Low', 'description': 'Levo-Carnitine 6g\n\nLevo-Carnitine'}, {'id': 'BG002', 'title': 'Carnitine Medium', 'description': 'Levo-Carnitine 12 g\n\nLevo-Carnitine'}, {'id': 'BG003', 'title': 'Carnitine High', 'description': 'Levo-Carnitine 18 g\n\nLevo-Carnitine'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.22', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '67.51', 'spread': '12.01', 'groupId': 'BG001'}, {'value': '64.91', 'spread': '12.56', 'groupId': 'BG002'}, {'value': '59.67', 'spread': '14.50', 'groupId': 'BG003'}, {'value': '62', 'spread': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '238', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '250', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-15', 'size': 97319, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-16T09:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2012-08-11', 'resultsFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-16', 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta SOFA Score', 'timeFrame': '48 hours', 'description': 'Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '30646314', 'type': 'DERIVED', 'citation': 'Jones AE, Puskarich MA, Shapiro NI, Guirgis FW, Runyon M, Adams JY, Sherwin R, Arnold R, Roberts BW, Kurz MC, Wang HE, Kline JA, Courtney DM, Trzeciak S, Sterling SA, Nandi U, Patki D, Viele K. Effect of Levocarnitine vs Placebo as an Adjunctive Treatment for Septic Shock: The Rapid Administration of Carnitine in Sepsis (RACE) Randomized Clinical Trial. JAMA Netw Open. 2018 Dec 7;1(8):e186076. doi: 10.1001/jamanetworkopen.2018.6076.'}]}, 'descriptionModule': {'briefSummary': 'Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected or confirmed infection (examples include but are not limited to: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in clinical symptoms; a syndrome associated with a high risk of infection e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever of unknown origin with high suspicion of infectious etiology)\n2. Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;\n3. Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;\n4. Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine \\> 0.05mcg/kg/min; dopamine \\>10mcg/kg/min; Phenylephrine \\>0.4 mcg/kg/min; epinephrine \\> 0.05 mcg/kg/min;\n5. Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;\n6. Blood lactate level of \\>2.0 mMol/L.\n\nExclusion Criteria:\n\n1. Age \\<18 years;\n2. Pregnancy or breastfeeding;\n3. Any primary diagnosis other than sepsis;\n4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;\n5. Any history of seizures or a known seizure disorder;\n6. Any known inborn error of metabolism;\n7. Anticipated requirement for surgery that would interfere with the 12 hour infusion time;\n8. Active participation in another interventional study;\n9. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;\n10. Known systemic allergy to L-carnitine.\n11. Severe immunocompromised state (e.g. subject has neutropenia \\[receiving cytotoxic chemotherapy with absolute neutrophil count \\<500/uL or expected to decline to \\< 500 uL within the next three days).\n12. Active Treatment with Coumadin'}, 'identificationModule': {'nctId': 'NCT01665092', 'acronym': 'RACE', 'briefTitle': 'Rapid Administration of Carnitine in sEpsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock', 'orgStudyIdInfo': {'id': 'GM103799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Normal saline', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Carnitine Low', 'description': 'Levo-Carnitine 6g', 'interventionNames': ['Drug: Levo-Carnitine']}, {'type': 'EXPERIMENTAL', 'label': 'Carnitine Medium', 'description': 'Levo-Carnitine 12 g', 'interventionNames': ['Drug: Levo-Carnitine']}, {'type': 'EXPERIMENTAL', 'label': 'Carnitine High', 'description': 'Levo-Carnitine 18 g', 'interventionNames': ['Drug: Levo-Carnitine']}], 'interventions': [{'name': 'Levo-Carnitine', 'type': 'DRUG', 'armGroupLabels': ['Carnitine High', 'Carnitine Low', 'Carnitine Medium']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Univeristy of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'BIDMC', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'BWH', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '29316', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Alan Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Emergency Medicine', 'investigatorFullName': 'Alan Jones', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}