The Effect of High Dose Vitamin C in Burn Patients

This study has been withdrawn prior to enrollment.
(Inadequate resources to submit for approval)
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00350077
First received: July 6, 2006
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
  • Document a significantly higher number of mechanical ventilator free days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Document a significantly lower complication and infection rate in the Vitamin C group [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Document a lower incidence of organ failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350077

Locations
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
Investigators
Principal Investigator: Lorne H Blackbourne, MD United States Army Institute of Surgical Research
  More Information

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

Keywords provided by United States Army Institute of Surgical Research:
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 21, 2014