Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-28 @ 12:41 PM
Study NCT ID:
NCT01587261
Status:
WITHDRAWN
Last Update Posted:
2019-03-06
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C for Severe Thermal Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "This potential study was held up at the level of the FDA as they wouldn't approve and IND for the dose of vitamin C we wanted to use.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid Volume Requirements during the resuscitative phase after severe burn', 'timeFrame': '24 hours', 'description': 'Primary Outcome is to reduce fluid outcome requirements within the first 24 hours after severe thermal injury'}], 'secondaryOutcomes': [{'measure': 'Days of Ventilator Support Required', 'timeFrame': 'Hospital Course, estimated 6 weeks', 'description': 'Comparisons between cohorts as to the number of days of ventilator support will be measured'}, {'measure': 'Incidence of Abdominal Compartment Syndrome', 'timeFrame': 'Hospital Course, estimated 6 weeks'}, {'measure': 'Complication and infection rates in the Vitamin C group', 'timeFrame': 'Hospital Course, estimated 6 weeks'}, {'measure': 'Incidence of Renal Failure', 'timeFrame': 'Hospital Course, estimated 6 weeks', 'description': 'Incidence of renal failure between cohorts will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Vitamin C', 'Thermal Injury', 'Fluid Resuscitation'], 'conditions': ['Severe Thermal Injury, Greater Than 20% TBSA']}, 'descriptionModule': {'briefSummary': 'Animal and human data have supported the notion that administration of large doses of Vitamin C has beneficial effects on those subjects suffering from large burns. This effect may be due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C. These studies have demonstrated an improvement in urine output during resuscitation and reduced need for fluid volumes during resuscitation. In turn, these subjects demonstrated a reduction of wound edema, improved respiratory status (demonstrated by improvements in P:F ratios and reduced ventilator days), and no differences in terms of the possible complications of high-dose vitamin C administration between standard and treatment groups. The purpose of this study is to prospectively determine if Vitamin C can be safely used as an adjunctive treatment for patients suffering severe thermal injuries. High-dose vitamin C administered at a dose of 66mg/kg/hr during the acute phase of severe burn injuries will reduce fluid requirements in the first 48 hours after injury.', 'detailedDescription': 'Subjects presenting within 6 hours of a severe thermal injury, defined as greater than 20% of their total body surface area, or their family members will be approached on admission to Parkland Memorial Hospital and informed of the study. Those electing to participate in the study will be randomized to receive either high-dose vitamin C (66mg/kg/hr for the first 24 hours, this dosage is based on prior human studies) in addition to the standard resuscitation algorithm (as per the Parkland Formula) or to a control group receiving only the standard resuscitation algorithm. These subjects will then be followed during their hospital course for fluid requirements, urine output, infectious complication rates, liver/renal failure rates, abdominal compartment syndrome rates, and outcomes such as ICU days, total hospital days, and mortality. All adverse events will be monitored by a data safety monitoring board. Currently this is a planned pilot study with a future multi-center study planned based on the results of the pilot. These studies will help determine if high-dose vitamin C can be a safe adjunct to acute fluid resuscitation in severely burned patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects presenting with second and/or third degree burns exceeding 20% total body surface area but not greater than 75% TBSA\n2. Age between 18 and 65 years of age\n3. Subject has provided full written informed consent prior to the performance of any study-related treatment or procedure\n\nExclusion Criteria:\n\n1. Subjects presenting more than 6 hours from the estimated time of injury\n2. Known inclusion in another interventional clinical trial\n3. Subjects with known significant comorbidities (Congestive Heart Failure, Myocardial Infarction within 6 months of admission, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease or Renal Impairment)\n4. Pregnant Subjects\n5. Prisoners or Subjects Under Arrest\n6. Subjects younger than 18 years of age or older than 65 years of age\n7. Subjects with Baux Scores (Age plus % TBSA) greater than 120 (describing a non-survivable injury)\n8. Subjects with any known allergy to components included in injectable ascorbic acid\n9. Subjects with significant trauma burden (ISS \\> 15), including any open fracture, intracranial hemorrhage, or significant intra-abdominal injury.'}, 'identificationModule': {'nctId': 'NCT01587261', 'briefTitle': 'Vitamin C for Severe Thermal Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries', 'orgStudyIdInfo': {'id': 'KRA2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours', 'interventionNames': ['Drug: Vitamin C']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['High Dose Ascorbic Acid'], 'description': 'Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['LR'], 'description': 'Lactated Ringers solution will be given at a similar volume to what the treatment group will receive', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Kareem R AbdelFattah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT-Southwestern'}, {'name': 'Victoria Warren, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UT-Southwestern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}