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Preventive Sodium Lactate and Traumatic Brain Injury

NCT00995683 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-07-12

No results posted yet for this study

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.

Conditions

  • Head Trauma

Interventions

DRUG

half molar sodium lactate

intravenous infusion of 0.5 ml/kg during 48 hours

DRUG

isotonic sodium chloride

intravenous infusion of 0.5 ml/kg during 48 hours

Sponsors & Collaborators

  • Université de Nice Sophia Antipolis

    collaborator OTHER

  • Medical University of Grenoble

    collaborator OTHER

  • Institut d'Anesthesiologie des Alpes Maritimes

    lead OTHER

Principal Investigators

  • Carole Ichai, MD, PhD · Institut d'Anesthesiologie des Alpes Maritimes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995683 on ClinicalTrials.gov