Skip to content

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02019810
Acronym
DEBITC
Enrollment
20
Registered
2013-12-24
Start date
2014-10-31
Completion date
2016-10-31
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Traumatic Brain Injury With High Cerebral Pressure

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.

Interventions

DRUGNorepinephrine
DRUGDobutamine and norepinephrine

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean blood flow velocityAfter one hour of treatmentMean 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

MeasureTime frameDescription
Evolution of brain oxygenation under treatmentDuring one hour of treatmentComparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine
Dobutamine dosesAfter one hour of treatmentDobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone
Resistivity index on renal dopplerAfter one hour of treatmentMeasure of resistivity index on renal doppler after one hour of treatment with and without dobutamine
Pulsatility index on renal dopplerAfter one hour of treatmentMeasure 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 modificationsDuring one hour of treatmentComparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine

Countries

France

Contacts

Primary ContactGilles Francony, MD
0033476766688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026