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临床试验/NCT05569993
NCT05569993尚未招募早期 1 期

Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial

Assiut University0 个研究点目标入组 60 人开始时间: 2022年10月30日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
60
主要终点
The duration of ICU stay

研究概览

简要总结

Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system.

Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status

详细描述

The term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates.

Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects.

Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions.

Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?

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, Outcomes Assessor)

盲法说明

Double blinded clinical trial Masking for patient,their relatives and outcome assessor

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 60 years old
  • mild to moderate head trauma

排除标准

  • patients with concurrent cns dysfunction
  • Renal failure patient
  • diabetic patients with neuropathy

研究组 & 干预措施

Glutamine group

Active Comparator

30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU

干预措施: Glutamine (Drug)

Placcebo group

Placebo Comparator

30 patients will recieve placcebo for first 7 days in ICU

干预措施: Placcebo (Other)

结局指标

主要结局

The duration of ICU stay

时间窗: First 30 days

The duration of ICU stay after glutamine adiminstration

次要结局

  • The incidence of Convulsions(30 days)
  • Consiousness level by Glagow coma scale(30 days)

研究者

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

Engy Raafat Youssif

Assistant lecuturer

Assiut University

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