Viewing Study NCT00350077



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Study NCT ID: NCT00350077
Status: WITHDRAWN
Last Update Posted: 2011-12-20
First Post: 2006-07-06

Brief Title: The Effect of High Dose Vitamin C in Burn Patients
Sponsor: United States Army Institute of Surgical Research
Organization: United States Army Institute of Surgical Research

Study Overview

Official Title: The Effect of High Dose Versus Low Dose Intravenous Vitamin C Ascorbic Acidon Burn Injury Resuscitation
Status: WITHDRAWN
Status Verified Date: 2011-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Inadequate resources to submit for approval
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Vitamin C
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None