Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury

University of Zurich1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2009年11月1日最近更新: 2011年3月16日

适应症

试验速览

阶段: 4 期
发起方: University of Zurich
入组人数: 48
试验地点: 1
主要终点: Reduced amount of fluids given

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RCT colloids versus cristalloids only in severe burn victims.

Trial with medicinal product

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns)
•Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56).
•Patients or relatives can understand the study information and the provided information in German language

排除标准

•Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation
•Pregnancy
•No informed consent
•Known allergic reaction to HES
•Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner.
•Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see "Arzneimittelkompendium der Schweiz® - Documed")

结局指标

主要结局

Reduced amount of fluids given

时间窗: 3 days

次要结局

未报告次要终点

研究者

发起方

University of Zurich

申办方类型

Other

研究点 (1)

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