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临床试验/NCT01455376
NCT01455376已完成不适用

Effect of Exogenous Lactate Infusion on Neurocognitive Function of Patients With Mild Traumatic Brain Injury

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3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
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes in neurocognitive function

研究概览

简要总结

Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI disability could stem from cognitive, physical, psychological and social dysfunction which resulted in significant disability and unemployment. Long-term behavioral impairments which affected the individual's occupation, lifestyle, and family frequently occurred in individuals with mild to moderate brain injuries who physically fully recovered. In-vitro and in-vivo studies showed a better recovery of cognitive function after administration of exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on cognitive function assessed by Mini Mental State Examination(MMSE)scale.

详细描述

Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI disability could stem from cognitive, physical, psychological and social dysfunction which resulted in significant disability and unemployment. Cognitive impairment post traumatic brain injury is due to the disruption of brain vascular bed and microstructural damage. Currently, there is no specific therapy for individual with mild TBI. Neuropsychological assessment and early management immediately after mild traumatic brain injury have been shown to reduce long term cognitive disability. In-vitro and in-vivo studies showed a better recovery of cognitive function after administration of exogenous lactate in traumatic brain injury.

The role of lactate in cerebral energy metabolism has been investigated widely. The ability of lactate as the sole energy substrate to support synaptic function has been demonstrated by different studies. In many studies, lactate has been proven to be a preferred or even an obligatory substrate over glucose for aerobic energy production during the initial stage of recovery from cerebral ischemia or hypoxia for recovery from ATP-depleted synaptic function and exogenously supplied lactate can support the early recovery of synaptic function after hypoxia.

However, the clinical studies evaluated the effect of lactate administration on cognitive function in patients with mild traumatic brain injury are still limited. Therefore, we conduct a study to evaluate the effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on cognitive function assessed by Mini Mental State Examination (MMSE) score evolution in mild traumatic brain injury compared with patients receiving hyperosmolar sodium chloride 3 % as a control group. MMSE score can be used as a tool to describe cognitive function.

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
Single (Participant)

入排标准

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

入选标准

  • Mild traumatic brain injury
  • Glasgow Coma Scale (GCS) of 14-15
  • Requires emergency neurosurgery procedures
  • Physical status ASA I-II
  • Onset of trauma < 9 hours

排除标准

  • Multiple injury
  • Pregnancy/lactation
  • History of alcohol or barbiturate consumption prior to the injury

研究组 & 干预措施

Hyperosmolar sodium lactate

Experimental

Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery

干预措施: hyperosmolar sodium lactate (Drug)

结局指标

主要结局

Changes in neurocognitive function

时间窗: 24 hours, 30 days, and 90 days post surgery

The investigators evaluate the changes in neurocognitive function at several time points (24 hours, 30 days, and 90 days post surgery) using Mini Mental State Examination (MMSE) score in both groups. Osmolality and sodium level are also recorded in order to confirm that hyperosmolar sodium lactate is safe for traumatic brain injury patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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