NCT00319345

Brief 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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

June 23, 2010

Status Verified

April 1, 2006

First QC Date

April 27, 2006

Last Update Submit

June 22, 2010

Conditions

Severe Trauma Brain InjuryIntracranial Hypertension

Keywords

Traumatic brain injuryIntracranial pressureOsmotherapyGlasgow outcome scoreMannitolSodium-Lactate

Outcome Measures

Primary Outcomes (1)

  • Efficiency to decrease ICP during IHE episodes

Secondary Outcomes (1)

  • Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution

Interventions

Mannitol, Sodium-LactateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 65 years
  • severe traumatic brain injury
  • prehospital glasgow coma scale \< 9
  • rapid neurological worsening before admission

You may not qualify if:

  • neurosurgical intervention
  • polytrauma
  • bilatéral fixed dilated pupils
  • motorscore \< 4
  • prolonged episode of hypoxia or arterial hypotension
  • abundant rinorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06006, France

Location

MeSH Terms

Conditions

Intracranial HypertensionBrain Injuries, Traumatic

Interventions

MannitolSodium Lactate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesLactatesHydroxy AcidsCarboxylic Acids

Study Officials

  • Carole R ICHAI, MD-PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

November 1, 2003

Study Completion

November 1, 2005

Last Updated

June 23, 2010

Record last verified: 2006-04

Locations

FR(1)