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

Primary Purpose

Burns

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intravenous Vitamin C

Vitamin C

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

United States Army Institute of Surgical Research

Outcomes

Primary Outcome Measures

Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group

Document a significantly higher number of mechanical ventilator free days

Document a significantly lower complication and infection rate in the Vitamin C group

Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level

Secondary Outcome Measures

Document a lower incidence of organ failure

Full Information

NCT ID

NCT00350077

First Posted

July 6, 2006

Last Updated

December 19, 2011

Sponsor

United States Army Institute of Surgical Research

Collaborators

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00350077

Brief Title

The Effect of High Dose Vitamin C in Burn Patients

Acronym

Vitamin C

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Inadequate resources to submit for approval

Study Start Date

July 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United States Army Institute of Surgical Research

Collaborators

University of Miami

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

Burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravenous Vitamin C

Intervention Description

vitamin C IV during 24 hour period following burn

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Intervention Description

IV vitamin C

Primary Outcome Measure Information:

Title

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

Title

Document a significantly higher number of mechanical ventilator free days

Time Frame

7 days

Title

Document a significantly lower complication and infection rate in the Vitamin C group

Time Frame

7 days

Title

Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Document a lower incidence of organ failure

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorne H Blackbourne, MD

Organizational Affiliation

United States Army Institute of Surgical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

United States Army Institute of Surgical Research

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8300697

Citation

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.

Results Reference

background

PubMed Identifier

10722036

Citation

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.

Results Reference

background

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The Effect of High Dose Vitamin C in Burn Patients

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