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

Primary Purpose

Severe Traumatic Brain Injury With High Cerebral Pressure

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Norepinephrine
Dobutamine and norepinephrine
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Traumatic Brain Injury With High Cerebral Pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grenoble University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Noradrenaline alone

Noradrenaline + dobutamine

Arm Description

Treatment for 30 minutes with noradrenaline alone

Treatment with noradrenaline and dobutamine for 30 minutes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2013
Last Updated
August 14, 2015
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02019810
Brief Title
Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury
Acronym
DEBITC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury With High Cerebral Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noradrenaline alone
Arm Type
Active Comparator
Arm Description
Treatment for 30 minutes with noradrenaline alone
Arm Title
Noradrenaline + dobutamine
Arm Type
Experimental
Arm Description
Treatment with noradrenaline and dobutamine for 30 minutes
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Type
Drug
Intervention Name(s)
Dobutamine and norepinephrine
Primary Outcome Measure Information:
Title
Mean blood flow velocity
Description
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
Time Frame
After one hour of treatment
Secondary Outcome Measure Information:
Title
Evolution of brain oxygenation under treatment
Description
Comparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine
Time Frame
During one hour of treatment
Title
Dobutamine doses
Description
Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone
Time Frame
After one hour of treatment
Title
Resistivity index on renal doppler
Description
Measure of resistivity index on renal doppler after one hour of treatment with and without dobutamine
Time Frame
After one hour of treatment
Title
Pulsatility index on renal doppler
Description
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)
Time Frame
After one hour of treatment
Title
Cardiac output modifications
Description
Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine
Time Frame
During one hour of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Francony, MD
Phone
0033476766688
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Francony, MD
First Name & Middle Initial & Last Name & Degree
Pierre Bouzat, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean-François Payen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pierre Lavagne, MD
First Name & Middle Initial & Last Name & Degree
Julien Picard, MD
First Name & Middle Initial & Last Name & Degree
Dominique Falcon, MD
First Name & Middle Initial & Last Name & Degree
Marie-Christine Herault, MD
First Name & Middle Initial & Last Name & Degree
Philippe Declety, MD
First Name & Middle Initial & Last Name & Degree
Sebastien Thomas, MD
First Name & Middle Initial & Last Name & Degree
Marc Vinclair, MD
First Name & Middle Initial & Last Name & Degree
Marie-Cécile Fevre, MD
First Name & Middle Initial & Last Name & Degree
Charles Canet, MD
First Name & Middle Initial & Last Name & Degree
Bashar Oummahan, MD
First Name & Middle Initial & Last Name & Degree
Jerome Hanna, MD

12. IPD Sharing Statement

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

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