Effect of Exogenous Lactate on Neurocognitive in Brain Trauma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitas Padjadjaran
ClinicalTrials.gov Identifier:
NCT01455376
First received: October 5, 2011
Last updated: October 20, 2011
Last verified: October 2011

October 5, 2011
October 20, 2011
March 2010
June 2010   (final data collection date for primary outcome measure)
Changes in neurocognitive function [ Time Frame: 24 hours, 30 days, and 90 days post surgery ] [ Designated as safety issue: Yes ]
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
Changes in neurocognitive function [ Time Frame: 24 hours, 30 days, and 90 days post surgery ] [ Designated as safety issue: Yes ]
We 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
Complete list of historical versions of study NCT01455376 on ClinicalTrials.gov Archive Site
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Effect of Exogenous Lactate on Neurocognitive in Brain Trauma
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Traumatic Brain Injury
Drug: hyperosmolar sodium lactate
Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
Other Name: Totilac
  • No Intervention: Hyperosmolar sodium chloride
    Patients in this group received intravenous infusion of hyperosmolar Sodium Chloride 3% at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
  • Experimental: Hyperosmolar sodium lactate
    Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
    Intervention: Drug: hyperosmolar sodium lactate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
14 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01455376
AN-001.2011
Yes
Universitas Padjadjaran
Universitas Padjadjaran
Not Provided
Principal Investigator: Tatang Bisri, MD,PhD,Prof Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung
Universitas Padjadjaran
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP