Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 11:22 PM
Study NCT ID:
NCT01739361
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis
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': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'djanz@lsuhsc.edu', 'phone': '504-568-3167', 'title': 'Dr. David R Janz, MD, MSc, Assistant Professor of Medicine', 'organization': 'LSU Health Sciences Center New Orleans'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for the duration of hospital stay, an average of 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'AST or ALT >400 U/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'F2-isoprostanes After 72 Hours of Acetaminophen or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '24.97', 'upperLimit': '43.47'}, {'value': '40.15', 'groupId': 'OG001', 'lowerLimit': '29.67', 'upperLimit': '61.8'}]}]}], 'analyses': [{'pValue': '0.353', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours after randomization', 'description': 'F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients will be followed through the end of their hospital stay, an average of 5 weeks', 'description': 'percent of patients who died in the hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '.61', 'upperLimit': '1.44'}, {'value': '1.36', 'groupId': 'OG001', 'lowerLimit': '.83', 'upperLimit': '2.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': 'serum creatinine measurements at 72 hours', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.\n\nAcetaminophen'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.\n\nplacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '64'}, {'value': '58.5', 'groupId': 'BG001', 'lowerLimit': '47.5', 'upperLimit': '63.5'}, {'value': '55.5', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2012-11-26', 'resultsFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-19', 'studyFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F2-isoprostanes After 72 Hours of Acetaminophen or Placebo', 'timeFrame': '72 hours after randomization', 'description': 'F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.'}], 'secondaryOutcomes': [{'measure': 'In-hospital Mortality', 'timeFrame': 'Patients will be followed through the end of their hospital stay, an average of 5 weeks', 'description': 'percent of patients who died in the hospital'}, {'measure': 'Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo', 'timeFrame': '72 hours', 'description': 'serum creatinine measurements at 72 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Sepsis']}, 'descriptionModule': {'briefSummary': 'Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased risk of death. Acetaminophen may have a protective effect in these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults with severe sepsis and detectable cell-free hemoglobin.\n\nThe primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation, as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin treated with acetaminophen will have better clinical outcomes, including decreased incidence of acute kidney injury and lower rates of hospital mortality, compared to those who receive placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Female \\>=18 years old\n* Admitted to an Intensive Care Unit\n* Severe Sepsis\n* Detectable plasma cell-free hemoglobin\n\nExclusion Criteria:\n\n* patients who received acetaminophen in the past 48 hours prior to enrollment\n* intolerance or allergy to acetaminophen\n* measured AST/ALT \\>400 U/L in the 24 hours prior to enrollment\n* chronic liver disease defined by a Child-Pugh score \\>4\n* cannot swallow or have no enteral feeding access\n* patients with no detectable cell-free hemoglobin\n* patients transitioned to palliative care\n* pregnant patients or women of childbearing potential without a documented pregnancy test'}, 'identificationModule': {'nctId': 'NCT01739361', 'acronym': 'ACROSS', 'briefTitle': 'Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Phase IIa Randomized Controlled Trial of Acetaminophen for the Reduction of Oxidative Stress in Severe Sepsis', 'orgStudyIdInfo': {'id': 'APAP-121486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen', 'description': 'Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.', 'interventionNames': ['Drug: Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'armGroupLabels': ['Acetaminophen']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Janz', 'investigatorAffiliation': 'Vanderbilt University'}}}}