The Effect of High Dose Vitamin C in Burn Patients

Burns Clinical Trial

— Vitamin C  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00350077
• Other study ID #: H-05-045
• Status: Withdrawn
• Phase: N/A
• First received: July 6, 2006
• Last updated: December 19, 2011
• Start date: July 2006
• Est. completion date: March 2008

Study information

• Verified date: December 2011
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Intravenous Vitamin C
vitamin C IV during 24 hour period following burn
• Vitamin C
IV vitamin C

Locations

Country	Name	City	State
United States	United States Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research	University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group		72 hours	Yes
Primary	Document a significantly higher number of mechanical ventilator free days		7 days	No
Primary	Document a significantly lower complication and infection rate in the Vitamin C group		7 days	No
Primary	Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level		72 hours	No
Secondary	Document a lower incidence of organ failure		30 days	No