Trial | NCT01028339  Report issue

Title

Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values
Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury : a Comparative Study on the Effects on PtiO2 and Microdialysis Values

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    30
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.
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.
Study Started
Jul 31
2008
Primary Completion
Jun 30
2012
Study Completion
Dec 31
2012
Anticipated
Last Update
Aug 08
2012
Estimate

Drug Hypertonic saline

2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch

Drug Mannitol

Mannitol

Mannitol Active Comparator

Hypertonic saline Experimental

Criteria 

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 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
No Results Posted