Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

Last updated: August 7, 2012
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Terminated

Phase

3

Condition

Neurologic Disorders

Memory Loss

Traumatic Brain Injury

Treatment

N/A

Clinical Study ID

NCT01028339
SSH versus mannitol
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe Traumatic brain injury monitored with ICP, PtiO2 and cerebral microdialysis

  • And ICP> 20 mm Hg needing osmotherapy

  • And approval of the next of kind

Exclusion

Exclusion Criteria:

  • Bilateral fixed dilated pupils

  • Contra-indication to multimodal neuromonitoring

  • Previous CNS disease

  • Contra-indication to HS (cardiac insufficiency,...)

  • Natremia > 155 mmol/L or osmolarity > 320 mOsm/L

Study Design

Total Participants: 30
Study Start date:
July 01, 2008
Estimated Completion Date:
December 31, 2012

Study Description

Mannitol is frequently used to treat intracranial hypertension after TBI. However, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. It also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. Finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of TBI. especially through modulation of inflammatory reactions mechanisms and apoptosis.

We would like to prove non inferiority of hypertonic saline versus mannitol after TBI to allow its large utilization, especially by field military doctors with specific logistical problems. For that, more than the single Intracranial Pressure, we want to study effects of HS vs mannitol not only on PtiO2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.

Connect with a study center

  • HIA Sainte Anne

    Toulon, 83130
    France

    Site Not Available

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