Preventive Sodium Lactate and Traumatic Brain Injury
Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 10, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJuly 12, 2011
May 1, 2011
1.9 years
October 10, 2009
July 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
48 hours
Secondary Outcomes (1)
the neurological outcome at six months evaluated by the glasgow outcome scale
6 months
Study Arms (2)
half sodium lactate
EXPERIMENTALinfusion of 0.5 ml/kg/day during 48 hours
isotonic sodium chloride
ACTIVE COMPARATORinfusion of 0.5 ml/kg during 48 hours
Interventions
intravenous infusion of 0.5 ml/kg during 48 hours
intravenous infusion of 0.5 ml/kg during 48 hours
Eligibility Criteria
You may qualify if:
- severe head trauma with a glasgow coma scale less than 9
You may not qualify if:
- prehospital cardiac arrest
- severe hemorrhage shock
- severe circulatory or respiratory failure
- medullar trauma
- prehospital osmotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut d'Anesthesiologie des Alpes Maritimeslead
- Université de Nice Sophia Antipoliscollaborator
- Medical University of Grenoblecollaborator
Study Sites (1)
Institut d'Anesthesiologie des Alpes maritimes
Nice, Nice, 06000, France
Related Publications (1)
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.
PMID: 18807008RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carole Ichai, MD, PhD
Institut d'Anesthesiologie des Alpes Maritimes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2009
First Posted
October 15, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
July 12, 2011
Record last verified: 2011-05