A Phase 3 interventional study of Hypertonic saline and Mannitol in Traumatic Brain Injury, sponsored by Direction Centrale du Service de Santé des Armées. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-08.
Sponsored by Direction Centrale du Service de Santé des Armées · Phase 3, Interventional, and Treatment
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 93 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Mannitol
Drug: Hypertonic saline
2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch
Mannitol
Effects of HS versus mannitol on lactate/pyruvate ratio
Time frame: 20 min, 40 min, H1, H2, H3 and H4
Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose
Time frame: 20 min, 40 min, H1, H2, H3 and H4
Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy
Time frame: 20 min, 40 min, H1, H2, H3 et H4
Duration of ICP<20 mm Hg after osmotherapy
Time frame: 20 min, 40 min, H1, H2, H3 and H4
Interstitial osmolarity
Time frame: 20 min, 40 min and H1
Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma
Time frame: Day after osmotherapy
Length of stay
Time frame: After leaving the unit
Mortality
Time frame: 28th days
Glasgow outcome scale
Time frame: 6th month
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Direction Centrale du Service de Santé des Armées