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The Effect of High Dose Vitamin C in Burn Patients (Vitamin C)

This study has been withdrawn prior to enrollment.
(Inadequate resources to submit for approval)
University of Miami
Information provided by (Responsible Party):
United States Army Institute of Surgical Research Identifier:
First received: July 6, 2006
Last updated: December 19, 2011
Last verified: December 2011
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.

Condition Intervention
Burns Drug: Intravenous Vitamin C Drug: Vitamin C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation

Resource links provided by NLM:

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Intravenous Vitamin C
    vitamin C IV during 24 hour period following burn
    Drug: Vitamin C
    IV vitamin C
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.

Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00350077

United States, Texas
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
University of Miami
Principal Investigator: Lorne H Blackbourne, MD United States Army Institute of Surgical Research
  More Information

Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00350077     History of Changes
Other Study ID Numbers: H-05-045
Study First Received: July 6, 2006
Last Updated: December 19, 2011

Keywords provided by United States Army Institute of Surgical Research:

Additional relevant MeSH terms:
Wounds and Injuries
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on September 19, 2017