The Effect of High Dose Vitamin C in Burn Patients

Study Overview
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Brief Summary
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The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours.

Detailed Description
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Adequate fluid resuscitation in burn injured patients to allow adequate renal blood flow has been the hallmark of burn care in the last 50 years. The danger of exceeding the optimal intravenous fluid resuscitation has resulted in severe complications including abdominal compartment syndrome, loss of upper airway control, extremity compartment syndromes and pulmonary edema. Hig dose vitamin C infusion during the first 24 hours of burn resuscitation has been documented to decrease the overall amount of intravenous fluid needed to provide for adequate renal perfusion and hemodynamic stability in multiple animal model studies. High dose vitamin C is thought to decrease postburn microvascular protein and fluid leakage by reducing postburn lipid oxygenation caused by burn injury generated free radicals.

Official Title
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The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation

Conditions
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Burns

Intervention / Treatment
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* Drug: Intravenous Vitamin C
* Drug: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 20% total body surface area full and partial thickness burns Admitted to the USAISR burn center within 10 hours post injury Exclusion Criteria: Pregnant or breast feeding Documented preadmission or admission renal failure History of glucose-6-phosphate dehydrogenase deficiency, kidney stoves, gout or sickle cell Electrical injury Renal replacement of any kind<24 hours after admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous Vitamin C|vitamin C IV during 24 hour period following burn|
|Drug: Vitamin C|IV vitamin C|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group |  | 72 hours | 
| Document a significantly higher number of mechanical ventilator free days |  | 7 days | 
| Document a significantly lower complication and infection rate in the Vitamin C group |  | 7 days | 
| Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document a lower incidence of organ failure |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns