Clinical trial NCT02380482: Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
Official title: Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Myocardial dysfunction
Transthoracic echocardiography
Speckle tracking
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.


Eligibility criteria: TBI patients

Inclusion Criteria:

* Isolated and non opened traumatic brain injury
* 18 - 65 years old
* Intubated and mechanically ventilated
* Glasgow score \< or = 9 or
* Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
* Medical insurance

Exclusion Criteria:

* Treated major cardiovascular risks factors
* cardiovascular past medical history (acute cardiovascular event)
* Cardio thoracic surgery
* Brain dead status
* Inotrope drugs
* Severe polytraumatism
* Acute haemorrhage
* Non echogenic patient
* High level athlete
* Incapacitated person by law and pregnant women
* Discovery during echocardiography of underlying cardiomyopathy
* Urgent neurosurgery required

Control patients

Inclusion Criteria:

* Isolated and non opened traumatic brain injury
* 18 - 65 years old
* Intubated and mechanically ventilated
* Paired with TBI patient on age, BMI and sex
* Undergoing urgent non severe surgery
* Medical insurance

Exclusion Criteria:

* Traumatic brain injury
* Treated major cardiovascular risks factors
* cardiovascular past medical history (acute cardiovascular event)
* Cardio thoracic surgery
* Inotrope and vasopressive drugs
* Circulatory failure
* Non echogenic patient
* High level athlete
* Incapacitated person by law and pregnant women
* Discovery during echocardiography of underlying cardiomyopathy
* Urgent neurosurgery required

Primary outcomes:
measure: left ventricular ejection fraction
timeFrame: within the first 24 hours after injury
Secondary outcomes:
measure: Strain evaluation by speckle tracking (in percentage of systolic duration)
timeFrame: within the first 24 hours after injury
measure: Systolic strain rate by speckle tracking (in second)
timeFrame: within the first 24 hours after injury
measure: Diastolic strain rate by speckle tracking (in second)
timeFrame: within the first 24 hours after injury
measure: Systolic rotational velocity by speckle tracking (in degree by second)
timeFrame: within the first 24 hours after injury
measure: Diastolic rotational velocity by speckle tracking (in degree by second)
timeFrame: within the first 24 hours after injury
measure: Systolic twisting velocity by speckle tracking (in degree by second)
timeFrame: within the first 24 hours after injury
measure: Diastolic untwisting velocity by speckle tracking (in degree by second)
timeFrame: within the first 24 hours after injury
measure: Myocardial wall thickness (in millimeter)
timeFrame: within the first 24 hours after injury
measure: left ventricular diastolic function (cm/sec)
timeFrame: within the first 24 hours after injury
measure: Cardiac index
timeFrame: within the first 24 hours after injury
measure: tissue doppler imaging (cm/sec)
timeFrame: within the first 24 hours after injury
measure: right ventricular diastolic function
timeFrame: within the first 24 hours after injury
measure: right ventricular systolic function
timeFrame: within the first 24 hours after injury
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University hospital
Study officials:
References:
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