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

Condition(s) targeted: Severe Traumatic Brain Injury With High Cerebral Pressure

Intervention: Norepinephrine (Drug); Dobutamine and norepinephrine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Grenoble

Overall contact:
Gilles Francony, MD, Phone: 0033476766688

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Mean blood flow velocity

Secondary outcome:

Evolution of brain oxygenation under treatment

Dobutamine doses

Resistivity index on renal doppler

Pulsatility index on renal doppler

Cardiac output modifications

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Gilles Francony, MD, Phone: 0033476766688

Grenoble University Hospital, Grenoble 38043, France; Recruiting
Gilles Francony, MD, Principal 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, Sub-Investigator

Starting date: October 2014
Last updated: August 14, 2015