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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 4

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Treatments: Drug: variation of mannitol dose

Study type: Interventional

Funder types: Other

Identifiers

NCT00795587

0816

2008-004979-21 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• impeding neurosurgery
• hemodynamic or respiratory severe failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

mannitol high dose

Active Comparator group

Description:

mannitol 20% 0,8 g/ kg on minutes

Treatment:

Drug: variation of mannitol dose

mannitol low dose

Active Comparator group

Description:

mannitol 20% 0,4 g/ kg on minutes

Treatment:

Drug: variation of mannitol dose