Traumatic Brain Injury Clinical Trial
Official title:
Effect of Exogenous Lactate Infusion on Neurocognitive Function of Patients With Mild Traumatic Brain Injury
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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