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Preventive Sodium Lactate and Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Medical University of Nice
Medical University of Grenoble
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT00995683
First received: October 10, 2009
Last updated: July 9, 2011
Last verified: May 2011
History of Changes
  Purpose

The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.


Condition Intervention Phase
Head Trauma
 Drug: half molar sodium lactate
Drug: isotonic sodium chloride
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the neurological outcome at six months evaluated by the glasgow outcome scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: half sodium lactate
infusion of 0.5 ml/kg/day during 48 hours
 Drug: half molar sodium lactate
intravenous infusion of 0.5 ml/kg during 48 hours
Other Name: sodium lactate
Active Comparator: isotonic sodium chloride
infusion of 0.5 ml/kg during 48 hours
 Drug: isotonic sodium chloride
intravenous infusion of 0.5 ml/kg during 48 hours
Other Name: sodium chloride

Detailed Description:
  • Intracranial hypertension is the most severe complication of severe head injury. This may lead to cerebral death or severe neurological outcome. To improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. Recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes.
  • Methods and Objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in ICU. The primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in ICU. Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance
  • Protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. Management of patients is the same for all patients. Treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. Sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. Based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group
  • Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe head trauma with a glasgow coma scale less than 9

Exclusion Criteria:

  • prehospital cardiac arrest
  • severe hemorrhage shock
  • severe circulatory or respiratory failure
  • medullar trauma
  • prehospital osmotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995683

Locations
France
Institut d'Anesthesiologie des Alpes maritimes
Nice, France, 06000
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Medical University of Nice
Medical University of Grenoble
Investigators
Principal Investigator: Carole Ichai, MD, PhD Institut d'Anesthesiologie des Alpes Maritimes
  More Information

Publications:

Responsible Party: Carole Ichai, Institut d'Anesthésiologie des Alpes Maritimes
ClinicalTrials.gov Identifier: NCT00995683     History of Changes
Other Study ID Numbers: PA-Lac-TBI
Study First Received: October 10, 2009
Last Updated: July 9, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
intracranial hypertension
neurological outcome
osmotherapy

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

ClinicalTrials.gov processed this record on May 16, 2013