Vitamin C for Severe Thermal Injuries (NCT01587261) | Clinical Trial Compass
WithdrawnPhase 2
Vitamin C for Severe Thermal Injuries
Stopped: 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.
United States0Started 2017-06
Plain-language summary
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.
Who can participate
Age range18 Years β 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Subjects presenting with second and/or third degree burns exceeding 20% total body surface area but not greater than 75% TBSA
β. Age between 18 and 65 years of age
β. Subject has provided full written informed consent prior to the performance of any study-related treatment or procedure
Exclusion criteria
β. Subjects presenting more than 6 hours from the estimated time of injury
β. Known inclusion in another interventional clinical trial
β. 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)
β. Pregnant Subjects
β. Prisoners or Subjects Under Arrest
β. Subjects younger than 18 years of age or older than 65 years of age
What they're measuring
1
Fluid Volume Requirements during the resuscitative phase after severe burn
Timeframe: 24 hours
Trial details
NCT IDNCT01587261
SponsorUniversity of Texas Southwestern Medical Center