Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT01590303
Status:
UNKNOWN
Last Update Posted:
2012-05-02
First Post:
2012-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Following Vitamin C Administration in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, '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': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sequential organ function assessment score (SOFA)', 'timeFrame': '28 days or discharge from intensive care unit', 'description': "Scoring system to determine the extent of a patient's organ function or rate of failure. The score based on 6 different scores; one each for respiratory, hepatic, cardiovascular, renal, coagulation, neurologic."}], 'secondaryOutcomes': [{'measure': 'Biomarkers as a measure of coagulation, inflammation and oxidative stress.', 'timeFrame': '28 days or discharge from intensive care unit', 'description': 'Vitamin C Assays - Plasma/WBC Cytokines (8- plex) Adhesion Molecules Procalcitonin C-Reactive Protein,H igh Sensitivity High Density Lipoprotein Cholesterol Tbars F2 isoprostane Neutrophil elastase Thrombomodulin Free DNA HIF-1α'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe sepsis'], 'conditions': ['Severe Sepsis']}, 'descriptionModule': {'briefSummary': 'This study is designed to determine if Vitamin C administration to septic patients will result in an improvement in organ dysfunction which occurs during a septic illness.\n\nHypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce the length of time on a ventilator, length of stay in the intensive care unit and in hospital.', 'detailedDescription': 'This study will measure biomarkers of inflammation, coagulation and oxidative stress. These biomarkers have been shown to be increased during periods of oxidative stress eg post-operative, trauma, sepsis. The investigators will determine if Vitamin C administration decreases oxidative stress and as a result, a decrease in the markers of organ dysfunction eg SOFA Scores. Ultimately, if the investigators show a decrease in injury to organs, will this result in a better outcome for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of severe sepsis\n* admitted to the intensive care unit\n\nExclusion Criteria:\n\n* allergy to Vitamin C\n* history of kidney stones\n* glucose-6-phosphate dehydrogenase deficiency\n* history of iron overload/hemochromatosis'}, 'identificationModule': {'nctId': 'NCT01590303', 'briefTitle': 'Outcome Following Vitamin C Administration in Sepsis', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.', 'orgStudyIdInfo': {'id': 'UWO HSREB #18803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit', 'interventionNames': ['Drug: Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo vehicle administered in same fashion as active treatment', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'description': 'Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit', 'armGroupLabels': ['Vitamin C']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Michael Sharpe, MD FRCPC', 'role': 'CONTACT', 'email': 'michael.sharpe@lhsc.on.ca'}, {'name': 'Tracey Bentall, RN', 'role': 'CONTACT', 'email': 'tracey.bentall@lhsc.on.ca', 'phone': '5196858500'}, {'name': 'Norman Smith, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudio Martin, MD FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tina Mele, MD FRCPC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre - University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Tracey Bentall, RN', 'role': 'CONTACT', 'email': 'tracey.bentall@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '32546'}, {'name': 'Michael D Sharpe, MD FRCPC', 'role': 'CONTACT', 'email': 'michael.sharpe@lhsc.on.ca', 'phone': '5196633030'}], 'overallOfficials': [{'name': 'Michael D Sharpe, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Sharpe', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}