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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
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Drug: hyperosmolar sodium lactate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Exogenous Lactate Infusion on Neurocognitive Function of Patients With Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Universitas Padjadjaran:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455376

Locations
Indonesia
Hasan Sadikin Hospital
Bandung, West Java, Indonesia, 40161
Sponsors and Collaborators
Universitas Padjadjaran
Investigators
Principal Investigator: Tatang Bisri, MD,PhD,Prof Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung
  More Information

No publications provided

Responsible Party: Universitas Padjadjaran
ClinicalTrials.gov Identifier: NCT01455376     History of Changes
Other Study ID Numbers: AN-001.2011
Study First Received: October 5, 2011
Last Updated: October 20, 2011
Health Authority: Indonesia: Departement Kesehatan (Department of Health)
Indonesia: National Agency of Drug and Food Control

Keywords provided by Universitas Padjadjaran:
brain injury
cognitive function
sodium lactate
MMSE score

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014