Severe Traumatic Brain Injury With High Cerebral PressurePhase 2DEBITCNCT02019810
Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury
A Phase 2 study testing Norepinephrine and Dobutamine and norepinephrine in people with Severe Traumatic Brain Injury With High Cerebral Pressure, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Traumatic Brain Injury With High Cerebral Pressure
- What is being tested?
- Norepinephrine and Dobutamine and norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Instable episodes of high cerebral pressure
- Craniectomy
- High cerebral pressure without TBI
- No autoregulation
- Current hemorrhagic shock
- Chronic cardiac failure
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Gilles Francony, MD contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38043
Gilles Francony, MD
Pierre Bouzat, MD, PhD
About this study
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.
- Being tested
- Norepinephrine, Dobutamine and norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Dobutamine and norepinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline alone | Active comparator | Treatment for 30 minutes with noradrenaline alone Receives: Drug: Norepinephrine |
| Noradrenaline + dobutamine | Experimental | Treatment with noradrenaline and dobutamine for 30 minutes Receives: Drug: Dobutamine and norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After one hour of treatment
Secondary outcomes (5)
Evolution of brain oxygenation under treatment
Comparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine
Measured: During one hour of treatment
Dobutamine doses
Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone
Measured: 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
Measured: 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)
Measured: After one hour of treatment
Cardiac output modifications
Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine
Measured: During one hour of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startOct 2014
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain Injury With High Cerebral PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019810
- Sponsor's protocol ID
- 2013-003276-13
- Acronym
- DEBITC
- Status last verified
- Aug 2015
- First submitted
- 18 Dec 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02019810
- Acronym / sponsor ID
- DEBITC / 2013-003276-13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline alone | Active comparator | Drug: NorepinephrineTreatment for 30 minutes with noradrenaline alone |
| Noradrenaline + dobutamine | Experimental | Drug: Dobutamine and norepinephrineTreatment with noradrenaline and dobutamine for 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Instable episodes of high cerebral pressure
- Craniectomy
- High cerebral pressure without TBI
- No autoregulation
- Current hemorrhagic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norepinephrine | Drug | Noradrenaline alone |
| Dobutamine and norepinephrine | Drug | Noradrenaline + dobutamine |
Primary outcome
Mean blood flow velocity
Time frame: 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
5 secondary outcomes
Evolution of brain oxygenation under treatment
Time frame: During one hour of treatment
Dobutamine doses
Time frame: After one hour of treatment
Resistivity index on renal doppler
Time frame: After one hour of treatment
Pulsatility index on renal doppler
Time frame: After one hour of treatment
Cardiac output modifications
Time frame: During one hour of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Francony, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norepinephrine and Dobutamine and norepinephrine in people with Severe Traumatic Brain Injury With High Cerebral Pressure, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles Francony, MD (0033476766688), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood flow velocity (time frame: After one hour of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.