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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Traumatic Brain Injury With High Cerebral Pressure
• Intervention / Treatment: Drug: Norepinephrine; Drug: Dobutamine and norepinephrine

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • Grenoble University Hospital
    • Principal Investigator: Gilles Francony, MD
    • Sub-Investigator: Pierre Bouzat, MD, PhD
    • Sub-Investigator: Jean-François Payen, MD, PhD
    • Sub-Investigator: Pierre Lavagne, MD
    • Sub-Investigator: Julien Picard, MD
    • Sub-Investigator: Dominique Falcon, MD
    • Sub-Investigator: Marie-Christine Herault, MD
    • Sub-Investigator: Philippe Declety, MD
    • Sub-Investigator: Sebastien Thomas, MD
    • Sub-Investigator: Marc Vinclair, MD
    • Sub-Investigator: Marie-Cécile Fevre, MD
    • Sub-Investigator: Charles Canet, MD
    • Sub-Investigator: Bashar Oummahan, MD
    • Sub-Investigator: Jerome Hanna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Noradrenaline alone; Treatment for 30 minutes with noradrenaline alone	Drug: Norepinephrine
Experimental: Noradrenaline + dobutamine; Treatment with noradrenaline and dobutamine for 30 minutes	Drug: Dobutamine and norepinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood flow velocity	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	After one hour of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of brain oxygenation under treatment	Comparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine	During one hour of treatment
Dobutamine doses	Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone	After one hour of treatment
Resistivity index on renal doppler	Measure of resistivity index on renal doppler after one hour of treatment with and without dobutamine	After one hour of treatment
Pulsatility index on renal doppler	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)	After one hour of treatment
Cardiac output modifications	Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine	During one hour of treatment

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Vasoconstrictor Agents; Norepinephrine; Dobutamine
• Other Study ID Numbers: 2013-003276-13