Back to results

Sodium-Lactate and Traumatic Brain Injury

Primary Purpose

Severe Trauma Brain Injury, Intracranial Hypertension

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Mannitol, Sodium-Lactate

About this trial

This is an interventional treatment trial for Severe Trauma Brain Injury focused on measuring Traumatic brain injury, Intracranial pressure, Osmotherapy, Glasgow outcome score, Mannitol, Sodium-Lactate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age between 18 and 65 years severe traumatic brain injury prehospital glasgow coma scale < 9 rapid neurological worsening before admission Exclusion Criteria: neurosurgical intervention polytrauma bilatéral fixed dilated pupils motorscore < 4 prolonged episode of hypoxia or arterial hypotension abundant rinorrhea

Sites / Locations

CHU de Nice

Outcomes

Primary Outcome Measures

Efficiency to decrease ICP during IHE episodes

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00319345

First Posted

April 27, 2006

Last Updated

June 22, 2010

Sponsor

Institut d'Anesthesiologie des Alpes Maritimes

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, PT Kalbe Farma Tbk

1. Study Identification

Unique Protocol Identification Number

NCT00319345

Brief Title

Sodium-Lactate and Traumatic Brain Injury

Official Title

Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2006

Overall Recruitment Status

Terminated

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut d'Anesthesiologie des Alpes Maritimes

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, PT Kalbe Farma Tbk

4. Oversight

5. Study Description

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)

Detailed Description

Osmotherapy with mannitol remains the first treatment currently recommended to treat intracranial hypertension in severe head injury.However, this treatment in not always efficient and is associated with side-effects and a transitory action. Hypertonic sodium-lactate, by its osmotic and energetic properties could be superior to mannitol to decrease ICP. Study objectives : to compare the effect of mannitol and sodium-lactate on ICP at the fourth hour after the start of infusion during IHE in severe traumatic brain injury (TBI) (main endpoint) ; to compare the percentage of successfully treated episodes between both treatments and to compare the neurological status after one year of evolution (glasgow outcome score)(secondary endpoints) Patients inclusion : adult severe TBI (glasgow coma score < 9) < 66 yrs Exclusion criteria : polytrauma, bilateral fixed dilated pupils, motor score < 4, neurosurgery, prolonged episode of hypoxia or arterial hypotension, 34 patients included from november 2003 to november 2004 and randomized into two groups : MAN group receiving mannitol 20% 100 ml in 15 min (17 patients, 36 episodes of IHE treated) and LAC group receiving semimolar sodium-lactate 100 ml in 15 min (17 patients, 37 episodes of IHE treated). For ethical reasons a rescue treatment in a crossover fashion was performed for each episode of IHE when the randomized treatment failed. Follow-up : one year after the TBI. Study end : november 30, 2005

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Trauma Brain Injury, Intracranial Hypertension

Keywords

Traumatic brain injury, Intracranial pressure, Osmotherapy, Glasgow outcome score, Mannitol, Sodium-Lactate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

34 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Mannitol, Sodium-Lactate

Primary Outcome Measure Information:

Title

Efficiency to decrease ICP during IHE episodes

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carole R ICHAI, MD-PhD

Official's Role

Study Director

Facility Information:

Facility Name

CHU de Nice

City

Nice

State/Province

Alpes Maritimes

ZIP/Postal Code

06006

Country

France

12. IPD Sharing Statement

Learn more about this trial

Sodium-Lactate and Traumatic Brain Injury

We'll reach out to this number within 24 hrs