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The Effect of High Dose Vitamin C in Burn Patients

NCT ID: NCT00350077

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Burns

Keywords

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Intravenous Vitamin C

vitamin C IV during 24 hour period following burn

Intervention Type DRUG

Vitamin C

IV vitamin C

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorne H Blackbourne, MD

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

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United States Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8300697 (View on PubMed)

Tanaka 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.

Reference Type BACKGROUND
PMID: 10722036 (View on PubMed)

Other Identifiers

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H-05-045

Identifier Type: -

Identifier Source: org_study_id