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

Sponsor

Direction Centrale du Service de Santé des Armées (Other)

Overall Status

Terminated

CT.gov ID

NCT01028339

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Drug: Hypertonic saline Drug: Mannitol	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mannitol	Drug: Mannitol Mannitol
Experimental: Hypertonic saline	Drug: Hypertonic saline 2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch

Arm

Intervention/Treatment

Active Comparator: Mannitol

Drug: Mannitol

Mannitol

Experimental: Hypertonic saline

Drug: Hypertonic saline

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

Outcome Measures

Primary Outcome Measures

Effects of HS versus mannitol on lactate/pyruvate ratio [20 min, 40 min, H1, H2, H3 and H4]

Secondary Outcome Measures

Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose [20 min, 40 min, H1, H2, H3 and H4]
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]
Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma [Day after osmotherapy]
Length of stay [After leaving the unit]
Mortality [28th days]
Glasgow outcome scale [6th month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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