NCT01028339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

3.9 years

First QC Date

December 3, 2009

Last Update Submit

August 7, 2012

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injuryPtiO2Cerebral microdialysisOsmotherapyhypertonic salinemannitol

Outcome Measures

Primary Outcomes (1)

  • Effects of HS versus mannitol on lactate/pyruvate ratio

    20 min, 40 min, H1, H2, H3 and H4

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Mannitol

ACTIVE COMPARATOR
Drug: Mannitol

Hypertonic saline

EXPERIMENTAL
Drug: Hypertonic saline

Interventions

Hypertonic salineDRUG

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

Hypertonic saline
MannitolDRUG

Mannitol

Mannitol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIA Sainte Anne

Toulon, 83130, France

Location

Related Publications (3)

  • 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.

    PMID: 12794404BACKGROUND

  • 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.

    PMID: 17297315BACKGROUND

  • 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.

    PMID: 16787640BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Saline Solution, HypertonicMannitol

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Henry BORET, MD

    Direction Centrale du Service de Santé des Armées

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecin en chef

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 9, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

FR(1)