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

Phase 4TerminatedNCT00795587

University Hospital, Grenoble3 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury Intracranial Hypertension

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adults * severe traumatic brain injury * intracranial hypertension requiring mannitol administration Exclusion Criteria: * impeding neurosurgery * hemodynamic or respiratory severe failure

Locations (1)

Universitary Hospital

Grenoble, France

Outcomes

Primary Outcomes

intracranial pressure

Time frame: 2 hours

Secondary Outcomes

transcranial doppler

Time frame: 2 h

brain PO2

Time frame: 2h

MAP

Time frame: 2h

Heart Rate

Time frame: 2h

biology (blood gases, natremia, hematocrit)

Time frame: 2h

diuresis

Time frame: 2h

fluid requirement

Time frame: 2h

Data from ClinicalTrials.gov

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