Sodium-Lactate and Traumatic Brain Injury

NCT00319345 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-06-23

No results posted yet for this study

Summary

The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

Conditions

  • Severe Trauma Brain Injury
  • Intracranial Hypertension

Interventions

DRUG

Mannitol, Sodium-Lactate

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • PT Kalbe Farma Tbk

    collaborator INDUSTRY
  • Institut d'Anesthesiologie des Alpes Maritimes

    lead OTHER

Principal Investigators

  • Carole R ICHAI, MD-PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2003-11-30
Completion
2005-11-30

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 NCT00319345 on ClinicalTrials.gov