Effect of Exogenous Lactate on Neurocognitive in Brain Trauma

NCT01455376 | Completed DMC

• 1 other identifier: AN-001.2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

brain injury; cognitive function; sodium lactate; MMSE score

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours, 30 days, and 90 days post surgery

Study Arms (2)

Hyperosmolar sodium chloride

NO INTERVENTION

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

Hyperosmolar sodium lactate

EXPERIMENTAL

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

Interventions

hyperosmolar sodium lactate DRUG

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

Also known as: Totilac

Hyperosmolar sodium lactate

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tatang Bisri, MD,PhD,Prof

  Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 19, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 21, 2011

Record last verified: 2011-10

Locations

ID (1)