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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury; Intracranial Hypertension

Intervention: variation of mannitol dose (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University Hospital, Grenoble

Official(s) and/or principal investigator(s):
Gilles Francony, MD, Principal Investigator, Affiliation: University Hospital, Grenoble

Summary

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

Clinical Details

Official title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: intracranial pressure

Secondary outcome:

transcranial doppler

brain PO2

MAP

Heart Rate

biology (blood gases, natremia, hematocrit)

diuresis

fluid requirement

Detailed description: traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adults

- severe traumatic brain injury

- intracranial hypertension requiring mannitol administration

Exclusion Criteria:

- impeding neurosurgery

- hemodynamic or respiratory severe failure

Locations and Contacts

Universitary Hospital, Grenoble 38043, France
Additional Information

Starting date: October 2008
Last updated: November 7, 2012

Page last updated: August 23, 2015

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