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The Effect of High Dose Vitamin C in Burn Patients

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00350077
Acronym
Vitamin C
Enrollment
0
Registered
2006-07-10
Start date
2006-07-31
Completion date
2008-03-31
Last updated
2011-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Burns

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 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.

Interventions

vitamin C IV during 24 hour period following burn

DRUGVitamin C

IV vitamin C

Sponsors

University of Miami
CollaboratorOTHER
United States Army Institute of Surgical Research
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 72 Years
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

Design outcomes

Primary

MeasureTime frame
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group72 hours
Document a significantly higher number of mechanical ventilator free days7 days
Document a significantly lower complication and infection rate in the Vitamin C group7 days
Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level72 hours

Secondary

MeasureTime frame
Document a lower incidence of organ failure30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026