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

Phase 2

• Conditions: Severe Traumatic Brain Injury With High Cerebral Pressure
• Interventions: Drug: Norepinephrine; Drug: Dobutamine and norepinephrine

• Registration Number: NCT02019810
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Study Start: 2014-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17
• Primary Completion: 2016-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Noradrenaline alone	Norepinephrine	Treatment for 30 minutes with noradrenaline alone
Noradrenaline + dobutamine	Dobutamine and norepinephrine	Treatment with noradrenaline and dobutamine for 30 minutes

Primary Outcome Measures

Name	Time	Method
Mean blood flow velocity	After one hour of treatment	Mean blood flow velocity averaged on the two middle cerebral arteries (right and left) measured one after after the initiation of treatment. Each velocity is calculated as an average on the 10 last minutes form continuous transcranial doppler monitoring

Secondary Outcome Measures

Name	Time	Method
Resistivity index on renal doppler	After one hour of treatment	Measure of resistivity index on renal doppler after one hour of treatment with and without dobutamine
Pulsatility index on renal doppler	After one hour of treatment	Measure of pulsatility index (PI) on renal doppler before and after one hour of treatment with and without dobutamine prediction of cerebral blood flow increase (patients with high initial renal PI)
Evolution of brain oxygenation under treatment	During one hour of treatment	Comparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine
Dobutamine doses	After one hour of treatment	Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone
Cardiac output modifications	During one hour of treatment	Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France