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

This study has been terminated.
(No patients enrolled during 2 years)
Information provided by (Responsible Party):
BORET Henry, Direction Centrale du Service de Santé des Armées Identifier:
First received: December 3, 2009
Last updated: August 7, 2012
Last verified: August 2012
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 Intervention Phase
Traumatic Brain Injury
Drug: Hypertonic saline
Drug: Mannitol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Direction Centrale du Service de Santé des Armées:

Primary Outcome Measures:
  • Effects of HS versus mannitol on lactate/pyruvate ratio [ Time Frame: 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 [ Time Frame: 20 min, 40 min, H1, H2, H3 and H4 ]
  • Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy [ Time Frame: 20 min, 40 min, H1, H2, H3 et H4 ]
  • Duration of ICP<20 mm Hg after osmotherapy [ Time Frame: 20 min, 40 min, H1, H2, H3 and H4 ]
  • Interstitial osmolarity [ Time Frame: 20 min, 40 min and H1 ]
  • Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma [ Time Frame: Day after osmotherapy ]
  • Length of stay [ Time Frame: After leaving the unit ]
  • Mortality [ Time Frame: 28th days ]
  • Glasgow outcome scale [ Time Frame: 6th month ]

Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mannitol Drug: Mannitol
Experimental: Hypertonic saline Drug: Hypertonic saline
2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01028339

HIA Sainte Anne
Toulon, France, 83130
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Principal Investigator: Henry BORET, MD Direction Centrale du Service de Santé des Armées
  More Information

Responsible Party: BORET Henry, Médecin en chef, Direction Centrale du Service de Santé des Armées Identifier: NCT01028339     History of Changes
Other Study ID Numbers: SSH versus mannitol
Study First Received: December 3, 2009
Last Updated: August 7, 2012

Keywords provided by Direction Centrale du Service de Santé des Armées:
traumatic brain injury
Cerebral microdialysis
hypertonic saline

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on April 28, 2017