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

NCT ID: NCT01028339

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury

Keywords

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traumatic brain injury PtiO2 Cerebral microdialysis Osmotherapy hypertonic saline mannitol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mannitol

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

Mannitol

Hypertonic saline

Group Type EXPERIMENTAL

Hypertonic saline

Intervention Type DRUG

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

Interventions

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Hypertonic saline

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

Intervention Type DRUG

Mannitol

Mannitol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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BORET Henry

Médecin en chef

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry BORET, MD

Role: PRINCIPAL_INVESTIGATOR

Direction Centrale du Service de Santé des Armées

Locations

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HIA Sainte Anne

Toulon, , France

Site Status

Countries

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France

References

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Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.

Reference Type BACKGROUND
PMID: 12794404 (View on PubMed)

Sakowitz OW, Stover JF, Sarrafzadeh AS, Unterberg AW, Kiening KL. Effects of mannitol bolus administration on intracranial pressure, cerebral extracellular metabolites, and tissue oxygenation in severely head-injured patients. J Trauma. 2007 Feb;62(2):292-8. doi: 10.1097/01.ta.0000203560.03937.2d.

Reference Type BACKGROUND
PMID: 17297315 (View on PubMed)

Soustiel JF, Vlodavsky E, Zaaroor M. Relative effects of mannitol and hypertonic saline on calpain activity, apoptosis and polymorphonuclear infiltration in traumatic focal brain injury. Brain Res. 2006 Jul 26;1101(1):136-44. doi: 10.1016/j.brainres.2006.05.045. Epub 2006 Jun 19.

Reference Type BACKGROUND
PMID: 16787640 (View on PubMed)

Other Identifiers

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SSH versus mannitol

Identifier Type: -

Identifier Source: org_study_id