Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

Traumatic Brain Injury Clinical Trial

— Echo-TC  

Official title:

Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380482
• Other study ID #: Echo-TC
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: December 8, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Other:
• Transthoracic echocardiography on TBI patients
Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma
• Transthoracic echocardiography on control patients
Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated

Locations

Country	Name	City	State
France	University hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (12)

Bahloul M, Chaari AN, Kallel H, Khabir A, Ayadi A, Charfeddine H, Hergafi L, Chaari AD, Chelly HE, Ben Hamida C, Rekik N, Bouaziz M. Neurogenic pulmonary edema due to traumatic brain injury: evidence of cardiac dysfunction. Am J Crit Care. 2006 Sep;15(5):462-70. — View Citation

Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, Fleisher LA, Froehlich JB, Gusberg RJ, Leppo JA, Ryan T, Schlant RC, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology; American Heart Association. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). J Am Coll Cardiol. 2002 Feb 6;39(3):542-53. Erratum in: J Am Coll Cardiol. 2006 Jun 6;47(11):2356. — View Citation

Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. — View Citation

Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015. — View Citation

Moussouttas M, Lai EW, Khoury J, Huynh TT, Dombrowski K, Pacak K. Determinants of central sympathetic activation in spontaneous primary subarachnoid hemorrhage. Neurocrit Care. 2012 Jun;16(3):381-8. doi: 10.1007/s12028-012-9673-5. — View Citation

Prathep S, Sharma D, Hallman M, Joffe A, Krishnamoorthy V, Mackensen GB, Vavilala MS. Preliminary report on cardiac dysfunction after isolated traumatic brain injury. Crit Care Med. 2014 Jan;42(1):142-7. doi: 10.1097/CCM.0b013e318298a890. — View Citation

Rosenthal G, Hemphill JC 3rd, Sorani M, Martin C, Morabito D, Obrist WD, Manley GT. Brain tissue oxygen tension is more indicative of oxygen diffusion than oxygen delivery and metabolism in patients with traumatic brain injury. Crit Care Med. 2008 Jun;36(6):1917-24. doi: 10.1097/CCM.0b013e3181743d77. — View Citation

Schrader H, Hall C, Zwetnow NN. Effects of prolonged supratentorial mass expansion on regional blood flow and cardiovascular parameters during the Cushing response. Acta Neurol Scand. 1985 Sep;72(3):283-94. — View Citation

Shanlin RJ, Sole MJ, Rahimifar M, Tator CH, Factor SM. Increased intracranial pressure elicits hypertension, increased sympathetic activity, electrocardiographic abnormalities and myocardial damage in rats. J Am Coll Cardiol. 1988 Sep;12(3):727-36. — View Citation

Shivalkar B, Van Loon J, Wieland W, Tjandra-Maga TB, Borgers M, Plets C, Flameng W. Variable effects of explosive or gradual increase of intracranial pressure on myocardial structure and function. Circulation. 1993 Jan;87(1):230-9. — View Citation

Song HS, Back JH, Jin DK, Chung PW, Moon HS, Suh BC, Kim YB, Kim BM, Woo HY, Lee YT, Park KY. Cardiac troponin T elevation after stroke: relationships between elevated serum troponin T, stroke location, and prognosis. J Clin Neurol. 2008 Jun;4(2):75-83. doi: 10.3988/jcn.2008.4.2.75. Epub 2008 Jun 20. — View Citation

Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with traumatic brain injury, 1979 through 1992. Success and failure. JAMA. 1995 Jun 14;273(22):1778-80. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection fraction		within the first 24 hours after injury	No
Secondary	Strain evaluation by speckle tracking (in percentage of systolic duration)		within the first 24 hours after injury	No
Secondary	Systolic strain rate by speckle tracking (in second)		within the first 24 hours after injury	No
Secondary	Diastolic strain rate by speckle tracking (in second)		within the first 24 hours after injury	No
Secondary	Systolic rotational velocity by speckle tracking (in degree by second)		within the first 24 hours after injury	No
Secondary	Diastolic rotational velocity by speckle tracking (in degree by second)		within the first 24 hours after injury	No
Secondary	Systolic twisting velocity by speckle tracking (in degree by second)		within the first 24 hours after injury	No
Secondary	Diastolic untwisting velocity by speckle tracking (in degree by second)		within the first 24 hours after injury	No
Secondary	Myocardial wall thickness (in millimeter)	2D transthoracic echography	within the first 24 hours after injury	No
Secondary	left ventricular diastolic function (cm/sec)	2D transthoracic echography	within the first 24 hours after injury	No
Secondary	Cardiac index	2D transthoracic echography	within the first 24 hours after injury	No
Secondary	tissue doppler imaging (cm/sec)	2D transthoracic echography	within the first 24 hours after injury	No
Secondary	right ventricular diastolic function	2D transthoracic echography	within the first 24 hours after injury	No
Secondary	right ventricular systolic function	2D transthoracic echography	within the first 24 hours after injury	No