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

Phase 3

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Hypertonic saline; Drug: Mannitol

• Registration Number: NCT01028339
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	Hypertonic saline	-
Mannitol	Mannitol	-

Primary Outcome Measures

Name	Time	Method
Effects of HS versus mannitol on lactate/pyruvate ratio	20 min, 40 min, H1, H2, H3 and H4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

HIA Sainte Anne; 🇫🇷 Toulon, France