Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 5:47 PM
Study NCT ID:
NCT03338569
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin C and Septic Shock
Sponsor:
Organization:
Raw JSON
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'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rreilkof@umn.edu', 'phone': '612-624-0999', 'title': 'Ronald Reilkoff, MD', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 9, 'seriousNumAtRisk': 64, 'deathsNumAffected': 26, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 8, 'seriousNumAtRisk': 61, 'deathsNumAffected': 16, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New or worsening heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Troponin w/o ST elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Maculopapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Elevated Troponin w/o ST elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New or worsening heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With ICU Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'All Cause Mortality at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Outcome is reported as the number of participants who have expired at 28 days post intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Vasopressor Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '45.2'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '47.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Outcome is reported as the duration in hours of vasopressor therapy post intervention administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of ICU Stay Post Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Lactate Clearance Post Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'timeFrame': '28 days', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure was not collected'}, {'type': 'SECONDARY', 'title': 'Rate of Lactate Clearance Post Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'title': '24 hours', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24, 48, 72, and 96 hours post intervention', 'description': 'Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed 96 hours of testing are included.'}, {'type': 'SECONDARY', 'title': 'Rate of Procalcitonin Clearance Post Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'timeFrame': '4 days', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Need for Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Outcome is reported as the number of participants who require renal replacement therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.7'}, {'value': '.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 days', 'description': 'Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom baseline and 96-hour creatinine data is available are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Sequential Organ Failure Assessment (SOFA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 days', 'description': 'SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom baseline and 96-hour SOFA scores were available are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 days', 'description': "APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom APACHE scores at baseline and 4 days post intervention were available are included.'}, {'type': 'SECONDARY', 'title': 'Total Intravenous Fluid Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'classes': [{'title': '6 hours post initiation of study treatment', 'categories': [{'measurements': [{'value': '.76', 'groupId': 'OG000', 'lowerLimit': '.36', 'upperLimit': '1.26'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '.72', 'upperLimit': '1.64'}]}]}, {'title': '24 hours post initiation of study treatment', 'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '4.7'}, {'value': '3.59', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '5.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.', 'unitOfMeasure': 'liters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom total intravenous fluid administration data was available are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo designed to mimic intervention\n\nPlacebo: Placebo designed to mimic intervention'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Vitamin C\n\nVitamin C: Continuous infusion of vitamin C'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '60.7', 'upperLimit': '80'}, {'value': '68.9', 'groupId': 'BG001', 'lowerLimit': '60.1', 'upperLimit': '79.9'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '60.1', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-17', 'size': 522879, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-07T08:39', 'hasProtocol': True}, {'date': '2020-01-23', 'size': 406963, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-13T11:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2017-10-31', 'resultsFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-13', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With ICU Mortality', 'timeFrame': '28 days', 'description': 'Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).'}, {'measure': 'All Cause Mortality at 28 Days', 'timeFrame': '28 days', 'description': 'Outcome is reported as the number of participants who have expired at 28 days post intervention'}], 'secondaryOutcomes': [{'measure': 'Duration of Vasopressor Therapy', 'timeFrame': '28 days', 'description': 'Outcome is reported as the duration in hours of vasopressor therapy post intervention administration'}, {'measure': 'Duration of ICU Stay Post Intervention Administration', 'timeFrame': '28 days', 'description': 'Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration'}, {'measure': 'Time to Lactate Clearance Post Intervention Administration', 'timeFrame': '28 days'}, {'measure': 'Rate of Lactate Clearance Post Intervention Administration', 'timeFrame': '24, 48, 72, and 96 hours post intervention', 'description': 'Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.'}, {'measure': 'Rate of Procalcitonin Clearance Post Intervention Administration', 'timeFrame': '4 days'}, {'measure': 'Number of Participants With Need for Renal Replacement Therapy', 'timeFrame': '4 days', 'description': 'Outcome is reported as the number of participants who require renal replacement therapy'}, {'measure': 'Change in Serum Creatinine', 'timeFrame': 'Baseline and 4 days', 'description': 'Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.'}, {'measure': 'Change in Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': 'Baseline and 4 days', 'description': 'SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.'}, {'measure': 'Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores', 'timeFrame': 'Baseline and 4 days', 'description': "APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death."}, {'measure': 'Total Intravenous Fluid Administered', 'timeFrame': '24 hours', 'description': 'Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '34982738', 'type': 'DERIVED', 'citation': 'Wacker DA, Burton SL, Berger JP, Hegg AJ, Heisdorffer J, Wang Q, Medcraft EJ, Reilkoff RA. Evaluating Vitamin C in Septic Shock: A Randomized Controlled Trial of Vitamin C Monotherapy. Crit Care Med. 2022 May 1;50(5):e458-e467. doi: 10.1097/CCM.0000000000005427. Epub 2022 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.', 'detailedDescription': 'This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.\n\n * Age ≥ 18 years\n * Septic shock as pragmatically defined as:\n\n o Order for intravenous antimicrobials with either procalcitonin \\> 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND\n * Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND\n * Lactate \\> 2 mmol/L 24 hr prior to enrollment AND\n * Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.\n\n * SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.\n * qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.\n\nExclusion Criteria:\n\n* • Unable to start infusion within 24 hours of septic shock identification\n\n * Currently pregnant or breastfeeding\n * Patient to receive comfort measures only\n * Cardiac Arrest\n * Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics \\< 48 hours post-operation\n * Participation in another study involving an investigational product within 30 days of the baseline visit\n * Allergy to Vitamin C\n * History of nephrolithiasis\n * History of G6PD deficiency\n * ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation\n * Clinical course that treating clinician decides would preclude safe participation'}, 'identificationModule': {'nctId': 'NCT03338569', 'briefTitle': 'Vitamin C and Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00000625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo designed to mimic intervention', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': '6000 mg per day Vitamin C supplement', 'interventionNames': ['Drug: Vitamin C']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['ascorbic acid'], 'description': 'Continuous infusion of vitamin C', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo designed to mimic intervention', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}