Clinical trial NCT01455376: Effect of Exogenous Lactate on Neurocognitive in Brain Trauma
Official title: Effect of Exogenous Lactate Infusion on Neurocognitive Function of Patients With Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: brain injury
cognitive function
sodium lactate
MMSE score
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in neurocognitive function
timeFrame: 24 hours, 30 days, and 90 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung
name: Tatang Bisri, MD,PhD,Prof
role: PRINCIPAL_INVESTIGATOR
References: