Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, PtiO2, Cerebral microdialysis, Osmotherapy, hypertonic saline, mannitol
Brief 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.
Detailed 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.
Interventions
DRUGHypertonic saline
2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch
DRUGMannitol
Mannitol
Sponsors
Direction Centrale du Service de Santé des Armées
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of HS versus mannitol on lactate/pyruvate ratio | 20 min, 40 min, H1, H2, H3 and H4 |
Secondary
| Measure | Time frame |
|---|---|
| Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy | 20 min, 40 min, H1, H2, H3 et H4 |
| Duration of ICP<20 mm Hg after osmotherapy | 20 min, 40 min, H1, H2, H3 and H4 |
| Interstitial osmolarity | 20 min, 40 min and H1 |
| Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose | 20 min, 40 min, H1, H2, H3 and H4 |
| Length of stay | After leaving the unit |
| Mortality | 28th days |
| Glasgow outcome scale | 6th month |
| Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma | Day after osmotherapy |
Countries
France
Outcome results
None listed