Preventive Sodium Lactate and Traumatic Brain Injury
Primary Purpose
Head Trauma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
half molar sodium lactate
isotonic sodium chloride
Sponsored by
About this trial
This is an interventional prevention trial for Head Trauma focused on measuring intracranial hypertension, neurological outcome, osmotherapy
Eligibility 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
Sites / Locations
- Institut d'Anesthesiologie des Alpes maritimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
half sodium lactate
isotonic sodium chloride
Arm Description
infusion of 0.5 ml/kg/day during 48 hours
infusion of 0.5 ml/kg during 48 hours
Outcomes
Primary Outcome Measures
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
Secondary Outcome Measures
the neurological outcome at six months evaluated by the glasgow outcome scale
Full Information
NCT ID
NCT00995683
First Posted
October 10, 2009
Last Updated
July 9, 2011
Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
Collaborators
Université de Nice Sophia Antipolis, Medical University of Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00995683
Brief Title
Preventive Sodium Lactate and Traumatic Brain Injury
Official Title
Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
Collaborators
Université de Nice Sophia Antipolis, Medical University of Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma
Keywords
intracranial hypertension, neurological outcome, osmotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
half sodium lactate
Arm Type
Experimental
Arm Description
infusion of 0.5 ml/kg/day during 48 hours
Arm Title
isotonic sodium chloride
Arm Type
Active Comparator
Arm Description
infusion of 0.5 ml/kg during 48 hours
Intervention Type
Drug
Intervention Name(s)
half molar sodium lactate
Other Intervention Name(s)
sodium lactate
Intervention Description
intravenous infusion of 0.5 ml/kg during 48 hours
Intervention Type
Drug
Intervention Name(s)
isotonic sodium chloride
Other Intervention Name(s)
sodium chloride
Intervention Description
intravenous infusion of 0.5 ml/kg during 48 hours
Primary Outcome Measure Information:
Title
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
the neurological outcome at six months evaluated by the glasgow outcome scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Ichai, MD, PhD
Organizational Affiliation
Institut d'Anesthesiologie des Alpes Maritimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut d'Anesthesiologie des Alpes maritimes
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18807008
Citation
Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20.
Results Reference
result
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Preventive Sodium Lactate and Traumatic Brain Injury
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