NCT00795587

Brief Summary

Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

November 20, 2008

Last Update Submit

November 7, 2012

Conditions

Traumatic Brain InjuryIntracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • intracranial pressure

    2 hours

Secondary Outcomes (7)

  • transcranial doppler

    2 h

  • brain PO2

    2h

  • MAP

    2h

  • Heart Rate

    2h

  • biology (blood gases, natremia, hematocrit)

    2h

  • +2 more secondary outcomes

Study Arms (2)

mannitol high dose

ACTIVE COMPARATOR

mannitol 20% 0,8 g/ kg on minutes

Drug: variation of mannitol dose

mannitol low dose

ACTIVE COMPARATOR

mannitol 20% 0,4 g/ kg on minutes

Drug: variation of mannitol dose

Interventions

variation of mannitol doseDRUG

in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes

mannitol high dosemannitol low dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • severe traumatic brain injury
  • intracranial hypertension requiring mannitol administration

You may not qualify if:

  • impeding neurosurgery
  • hemodynamic or respiratory severe failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gilles Francony, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

FR(1)