The Effect of High Dose Vitamin C in Burn Patients

Not Applicable

Withdrawn

• Conditions: Burns

• Registration Number: NCT00350077
• Lead Sponsor: United States Army Institute of Surgical Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-19
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Document a lower incidence of organ failure	30 days

Trial Locations

Locations (1)

United States Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States