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临床试验/NCT00350077
NCT00350077撤回不适用

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

United States Army Institute of Surgical Research2 个研究点 分布在 1 个国家开始时间: 2006年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >/= 20% total body surface area full and partial thickness burns
  • Admitted to the USAISR burn center within 10 hours post injury

排除标准

  • 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

结局指标

主要结局

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

时间窗: 72 hours

Document a significantly higher number of mechanical ventilator free days

时间窗: 7 days

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

时间窗: 7 days

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

时间窗: 72 hours

次要结局

  • Document a lower incidence of organ failure(30 days)

研究者

发起方
United States Army Institute of Surgical Research
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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