Study Stopped
Inadequate resources to submit for approval
The Effect of High Dose Vitamin C in Burn Patients
Vitamin C
The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedDecember 20, 2011
December 1, 2011
1.7 years
July 6, 2006
December 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group
72 hours
Document a significantly higher number of mechanical ventilator free days
7 days
Document a significantly lower complication and infection rate in the Vitamin C group
7 days
Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level
72 hours
Secondary Outcomes (1)
Document a lower incidence of organ failure
30 days
Interventions
vitamin C IV during 24 hour period following burn
IV vitamin C
Eligibility Criteria
You may qualify if:
- \>/= 20% total body surface area full and partial thickness burns
- Admitted to the USAISR burn center within 10 hours post injury
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Related 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. doi: 10.1097/00004630-199311000-00007.
PMID: 8300697BACKGROUNDTanaka 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. doi: 10.1001/archsurg.135.3.326.
PMID: 10722036BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorne H Blackbourne, MD
United States Army Institute of Surgical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 10, 2006
Study Start
July 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
December 20, 2011
Record last verified: 2011-12