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Effect of Exogenous Lactate on Neurocognitive in Brain Trauma

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
hyperosmolar sodium lactate
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring brain injury, cognitive function, sodium lactate, MMSE score

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasan Sadikin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Hyperosmolar sodium chloride

Hyperosmolar sodium lactate

Arm Description

Patients in this group received intravenous infusion of hyperosmolar Sodium Chloride 3% at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery

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

Outcomes

Primary Outcome Measures

Changes in neurocognitive function
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

Secondary Outcome Measures

Full Information

First Posted
October 5, 2011
Last Updated
October 20, 2011
Sponsor
Universitas Padjadjaran
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1. Study Identification

Unique Protocol Identification Number
NCT01455376
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Padjadjaran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
brain injury, cognitive function, sodium lactate, MMSE score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperosmolar sodium chloride
Arm Type
No Intervention
Arm Description
Patients in this group received intravenous infusion of hyperosmolar Sodium Chloride 3% at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
Arm Title
Hyperosmolar sodium lactate
Arm Type
Experimental
Arm Description
Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
Intervention Type
Drug
Intervention Name(s)
hyperosmolar sodium lactate
Other Intervention Name(s)
Totilac
Intervention Description
Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
Primary Outcome Measure Information:
Title
Changes in neurocognitive function
Description
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
Time Frame
24 hours, 30 days, and 90 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatang Bisri, MD,PhD,Prof
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Sadikin Hospital
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia

12. IPD Sharing Statement

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Effect of Exogenous Lactate on Neurocognitive in Brain Trauma

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