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临床试验/NCT02762539
NCT02762539Unknown不适用

Omega3 PUFA in Head Trauam

Mansoura University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Glasgow coma scale after 48 hour of infusion

研究概览

简要总结

Traumatic brain injury (TBI) is major health problem that stands as a significant cause of death and permanent disability. TBI is considered as global public health epidemic. On pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary. Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury Patients will be allocated into one of two groups through a random table generation; Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days

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
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mild to moderate head trauma

排除标准

  • sensitivity to SMOF lipid severe head trauama

研究组 & 干预措施

SMOF group

Experimental

SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days.

干预措施: omega-3 enriched SMOF lipid emusion (Drug)

结局指标

主要结局

Glasgow coma scale after 48 hour of infusion

时间窗: 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AlRefaey Kandeel

Dr

Mansoura University

研究点 (1)

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