Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350077
Recruitment Status : Withdrawn (Inadequate resources to submit for approval)
First Posted : July 10, 2006
Last Update Posted : December 20, 2011
University of Miami
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Burns Drug: Intravenous Vitamin C Drug: Vitamin C Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Vitamin C

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

Primary Outcome Measures :
  1. 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 ]
  2. Document a significantly higher number of mechanical ventilator free days [ Time Frame: 7 days ]
  3. Document a significantly lower complication and infection rate in the Vitamin C group [ Time Frame: 7 days ]
  4. Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level [ Time Frame: 72 hours ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350077

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Lorne H Blackbourne, MD United States Army Institute of Surgical Research

Layout table for additonal information
Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00350077     History of Changes
Other Study ID Numbers: H-05-045
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by United States Army Institute of Surgical Research:

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents