Severe Traumatic Brain Injury With High Cerebral Pressure Clinical Trial
— DEBITCSevere 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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | October 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Grenoble University Hospital | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Dobutamine doses | Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone | After one hour of treatment | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Cardiac output modifications | Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine | During one hour of treatment | No |