Clinical Trial: The Effect of High Dose Vitamin C in Burn Patients

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary: 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.
Sponsor: United States Army Institute of Surgical Research

Current Primary Outcome:

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


Original Primary Outcome:

  • Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group
  • Document a significantly higher number of mechanical ventilator free days
  • Document a significantly lower complication and infection rate in the Vitamin C group
  • Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level


Current Secondary Outcome: Document a lower incidence of organ failure [ Time Frame: 30 days ]

Original Secondary Outcome:

Information By: United States Army Institute of Surgical Research

Dates:
Date Received: July 6, 2006
Date Started: July 2006
Date Completion:
Last Updated: December 19, 2011
Last Verified: December 2011