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

D

Direction Centrale du Service de Santé des Armées

Status and phase

Terminated
Phase 3

Conditions

Traumatic Brain Injury

Treatments

Drug: Mannitol
Drug: Hypertonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01028339
SSH versus mannitol

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Mannitol
Active Comparator group
Treatment:
Drug: Mannitol
Hypertonic saline
Experimental group
Treatment:
Drug: Hypertonic saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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