Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-09 @ 12:16 AM
Study NCT ID:
NCT04138394
Status:
SUSPENDED
Last Update Posted:
2025-10-06
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VItamin C in Thermal injuRY: The VICToRY Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-18', 'size': 1035173, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-05T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Allocation will be random and concealed and will be blinded to everyone except the pharmacist at each site. The vitamin C will be sourced locally and prepared in a blinded manner by local research pharmacies that will be responsible for preparing study samples and delivering them to the ICU in a blinded fashion. The randomization system, which has proven reliable in several prior RCTs, has a robust audit trail, and will maintain concealment and blinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will be allocated to receive intravenous vitamin C at 50mg/kg, every 6 hrs for 96 hrs or placebo. We justify this proposed dosing strategy as the proposed dose of vitamin C has been shown to be safe and effective in patients with sepsis and lung injury whereas prior dosing strategies used in the burns literature (66 mg/kg/24 hours) have safety issues and are not long enough in duration. Control group: patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 666}}, 'statusModule': {'whyStopped': 'After the 1st interim analysis, on the recommendation of the DSMC, the steering committee decided to stop enrollment of new patients. The study is ongoing for the currently enrolled patients. More info to follow when available for public disclosure.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': '90 days', 'description': 'Duration of time in the ICU'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '90 days', 'description': 'Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.'}, {'measure': 'ICU readmission rate', 'timeFrame': '90 days', 'description': 'Incidents of readmission to ICU from within the hospital'}, {'measure': 'Hospital mortality', 'timeFrame': '90 days', 'description': 'Did the patient die in hospital or was the patient discharged?'}, {'measure': 'Hospital length of stay', 'timeFrame': '90 days', 'description': 'Duration of time in the hospital'}, {'measure': 'Wound healing', 'timeFrame': '90 days', 'description': 'time-to-95% graft closure'}, {'measure': 'Gram negative bacteremia', 'timeFrame': '90 days', 'description': 'Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli'}, {'measure': '6 month mortality', 'timeFrame': '6 months', 'description': 'Is the patient alive or deceased 6 months post admission.'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 months', 'description': 'Administration of the SF-36 questionnaire 6 months post admission'}], 'primaryOutcomes': [{'measure': 'Persistent Organ Dysfunction + Death', 'timeFrame': 'at 28 days', 'description': 'Persistent organ dysfunction (PODS)+death, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation)'}, {'measure': 'Time to discharge alive from hospital', 'timeFrame': '90 days', 'description': 'Time to discharge alive from hospital, a composite of mortality and length of stay is similar to "ventilator- free days", which is a widely accepted and commonly used outcome in intensive care research.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shock', 'Thermal Burn']}, 'descriptionModule': {'briefSummary': 'This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.', 'detailedDescription': 'In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death.\n\nWe aim to conduct a large-scale, multi-center randomized trial to evaluate the effect of high-dose (50mg/kg every 6 hours for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC.\n\nPatients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg every 6 hrs for 96 hrs. Patients in the control group will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. This study will be the first large international multi-centre trial examining the effects of high dose intravenous vitamin C in burn patients. It represents a unique collaboration of burn units worldwide that is coordinated by the Clinical Evaluation Research Unit, based in Kingston Ontario Canada, a coordinating center that has demonstrated the ability to run multi-center trials and translate findings into practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Deep 2nd and/or 3rd degree burns requiring skin grafting\n* Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)\n\nExclusion Criteria:\n\n* \\>24 hours from admission to participating hospital to consent.\n* Patients admitted to burn unit \\>24 from injury or accident.\n* Patients who are moribund (not expected to survive the next 72 hours).\n* Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.\n* Enrollment in another industry sponsored ICU intervention study.\n* Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n* Recent history of kidney stones (within the last year).\n* Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.'}, 'identificationModule': {'nctId': 'NCT04138394', 'acronym': 'VICToRY', 'briefTitle': 'VItamin C in Thermal injuRY: The VICToRY Trial', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Evaluation Research Unit at Kingston General Hospital'}, 'officialTitle': 'VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial', 'orgStudyIdInfo': {'id': 'VICToRY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours', 'interventionNames': ['Drug: Ascorbic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Ascorbic Acid', 'type': 'DRUG', 'otherNames': ['vitamin C'], 'description': 'Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).', 'armGroupLabels': ['Vitamin C']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['saline', 'D5W'], 'description': 'Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Burn Center Valleywise Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43210', 'city': 'Ohio City', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 41.48422, 'lon': -81.71124}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center - Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53211', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Ascension Columbia St. Mary's", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '6280', 'city': 'Charleroi', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Belgium Military Hospital, Military Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'B3H 3A6', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital, Hamilton Health Sciences Corporation', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'San José', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'facility': 'Hospital San Juan de Dios', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'BG Klinik Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '04129', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinikum St. George', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'RWTH Aachen University, Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Merheim Medical Center, Hospitals of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliche Unfallklinik Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '78290', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Hospital Central Dr. Ignacio Morones Prieto', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'city': 'Asunción', 'country': 'Paraguay', 'facility': 'Centro Nacional del Quemado y Cirugías Reconstructivas', 'geoPoint': {'lat': -25.28646, 'lon': -57.647}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': 'SW10 9NH', 'city': 'Chelsea', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.48755, 'lon': -0.16936}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'Mindelsohn Way', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'L35 5DR', 'city': 'Prescot', 'country': 'United Kingdom', 'facility': 'St Helens and Knowsley Hospitals NHS Trust', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'city': 'Wakefield', 'country': 'United Kingdom', 'facility': 'The Mid Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}], 'overallOfficials': [{'name': 'Daren K Heyland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Evaluation Research Unit at Kingston General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Daren Heyland, MD, MSc, FRCPC', 'investigatorFullName': 'Daren K. Heyland', 'investigatorAffiliation': 'Clinical Evaluation Research Unit at Kingston General Hospital'}}}}