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

NCT02380482 | Completed

• 1 other identifier: Echo-TC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Myocardial dysfunction; Transthoracic echocardiography; Speckle tracking

Outcome Measures

Primary Outcomes (1)

• left ventricular ejection fraction

  within the first 24 hours after injury

Secondary Outcomes (13)

• Strain evaluation by speckle tracking (in percentage of systolic duration)

  within the first 24 hours after injury

• Systolic strain rate by speckle tracking (in second)

  within the first 24 hours after injury

• Diastolic strain rate by speckle tracking (in second)

  within the first 24 hours after injury

• Systolic rotational velocity by speckle tracking (in degree by second)

  within the first 24 hours after injury

• Diastolic rotational velocity by speckle tracking (in degree by second)

  within the first 24 hours after injury

Study Arms (2)

Traumatic brain injury

OTHER

Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients * 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

Other: Transthoracic echocardiography on TBI patients

Controls

OTHER

Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria: * Intubated and mechanically ventilated * Undergoing urgent non severe surgery

Other: Transthoracic echocardiography on control patients

Interventions

Transthoracic echocardiography on TBI patients OTHER

Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma

Traumatic brain injury

Transthoracic echocardiography on control patients OTHER

Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated

Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated and non opened traumatic brain injury
• 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

You may not qualify if:

• 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
• Isolated and non opened traumatic brain injury
• years old

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University hospital

Grenoble, 38043, France

Location

Related Publications (13)

• 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.

  PMID: 16926367 BACKGROUND

• 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. doi: 10.1016/s0735-1097(01)01788-0. No abstract available.

  PMID: 11823097 BACKGROUND

• 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. doi: 10.1016/j.echo.2005.10.005. No abstract available.

  PMID: 16376782 BACKGROUND

• 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.

  PMID: 21338865 BACKGROUND

• 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.

  PMID: 22311230 BACKGROUND

• 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.

  PMID: 23963125 BACKGROUND

• 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.

  PMID: 18496376 BACKGROUND

• 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. doi: 10.1111/j.1600-0404.1985.tb00872.x.

  PMID: 4061050 BACKGROUND

• 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. doi: 10.1016/s0735-1097(88)80065-2.

  PMID: 3403832 BACKGROUND

• 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. doi: 10.1161/01.cir.87.1.230.

  PMID: 8419012 BACKGROUND

• 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.

  PMID: 19513307 BACKGROUND

• 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.

  PMID: 7769773 BACKGROUND

• Cuisinier A, Maufrais C, Payen JF, Nottin S, Walther G, Bouzat P. Myocardial function at the early phase of traumatic brain injury: a prospective controlled study. Scand J Trauma Resusc Emerg Med. 2016 Oct 28;24(1):129. doi: 10.1186/s13049-016-0323-3.

  PMID: 27793208 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 5, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

FR (1)