Clinical trial NCT00350077: The Effect of High Dose Vitamin C in Burn Patients
Official title: The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Keywords: Burns
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
Collaborators: name: University of Miami
First posted: 2006-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group
timeFrame: 72 hours
measure: Document a significantly higher number of mechanical ventilator free days
timeFrame: 7 days
measure: Document a significantly lower complication and infection rate in the Vitamin C group
timeFrame: 7 days
measure: Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level
timeFrame: 72 hours
Secondary outcomes:
measure: Document a lower incidence of organ failure
timeFrame: 30 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Lorne H Blackbourne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsuda T, Tanaka H, Yuasa H, Forrest R, Matsuda H, Hanumadass M, Reyes H. The effects of high-dose vitamin C therapy on postburn lipid peroxidation. J Burn Care Rehabil. 1993 Nov-Dec;14(6):624-9. doi: 10.1097/00004630-199311000-00007.
citation: Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.