Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury (DEBITC)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Unknown; Phase 2

Conditions: Severe Traumatic Brain Injury With High Cerebral Pressure

Treatments: Drug: Norepinephrine; Drug: Dobutamine and norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02019810

2013-003276-13

Details and patient eligibility

About

Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Traumatic brain injury (TBI) with pattern of oligemia (diastolic velocity < 30cm/second and/or mean velocity < 45cm/second measured with transcranial doppler or oxygen tissue pressure < 15mmHg)
• Closed traumatic brain injury
• Isolated TBI or polytraumatism
• Age between 18 and 65 years old
• Affiliated to a social security system

Exclusion criteria

• Instable episodes of high cerebral pressure
• Craniectomy
• High cerebral pressure without TBI
• No autoregulation
• Current hemorrhagic shock
• Chronic cardiac failure
• Chronic renal failure
• Hyperemia measured with transcranial doppler
• Short life expectancy
• Refused consent from the family
• Protected patients by the law
• Hypersensibility to one of the treatment or sulfites

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Noradrenaline alone

Active Comparator group

Description:

Treatment for 30 minutes with noradrenaline alone

Treatment:

Drug: Norepinephrine

Noradrenaline + dobutamine

Experimental group

Description:

Treatment with noradrenaline and dobutamine for 30 minutes

Treatment:

Drug: Dobutamine and norepinephrine