drugset / Trial / NCT01587261

Vitamin C for Severe Thermal Injuries

NCT01587261 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-06
Primary completion
2017-06
Completion
2017-12

Outcome

Outcome not reported

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.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 66 mg/kg —

Indications

No indication recorded.