Cardiac Dysfunction in Traumatic Brain Injury

NCT03566368 | Completed

• 1 other identifier: III, 3.02 Neurosciences
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Head Injury have been associated with varying degree of cardiac dysfunction resulting in adverse events during emergency surgery and during recover from head injury. This study intends to study the incidence and impact of cardiac dysfunction using electrocardiogram, transthoracic echocardiogram and cardiac enzyme levels in head injury patients during and following emergency surgery. Our results will facilitate better management, guide specific therapy and help in prognostication in this group of patients.

Conditions

Trauma, Head; Cardiac Complication

Keywords

Cardiac Dysfunction; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Incidence of Left Ventricular Ejection Fraction < 50% and change following surgery

  On ECHO performed using Ultrasonography (M-Turbo; Sonosite, Bothwell, WA, USA) using phased array transducer with a scanning frequency between 5 and 1 MHz - Ejection fraction calculated using simpson's Biplane method in 4 chamber and 2 chamber apical view.

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

• Incidence of Left ventricular regional wall motion abnormality and change following surgery

  On ECHO performed using Ultrasonography (M-Turbo; Sonosite, Bothwell, WA, USA) using phased array transducer with a scanning frequency between 5 and 1 MHz - Presence of regional wall motion abnormality assessed in Parasternal - long and short axis, Apical 4,2 and 5 chamber views.

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

Secondary Outcomes (16)

• ECG abnormality - Tachycardia

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

• ECG abnormality - Bradycardia

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

• ECG abnormaltiy - Prolonged PR interval

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

• ECG abnormality - Prolonged QRS duration

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

• ECG abnormality - ST-T changes

  Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.

Study Arms (1)

Study Group

Isolated Traumatic Brain Injury Patients requiring emergency surgical intervention.

Diagnostic Test: Electrocardiogram; Diagnostic Test: Transthoracic Echocardiogram; Diagnostic Test: Cardiac enzyme - Troponin I Levels

Interventions

Electrocardiogram DIAGNOSTIC_TEST

a 12 lead surface electrocardiogram taken after connecting limb and chest electrodes

Also known as: ECG

Study Group

Transthoracic Echocardiogram DIAGNOSTIC_TEST

Transthoracic echocardiogram performed to evaluate Cardiac function in parasternal - long and short axis, Apical - 4 chamber and 5 chamber views.

Also known as: ECHO

Study Group

Cardiac enzyme - Troponin I Levels DIAGNOSTIC_TEST

Blood sample - venous collected to measure blood troponin - I levels.

Also known as: TROP-I

Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients of head injury requiring emergency intracranial surgery presenting to National Institute of Mental health and Neurosciences.

You may qualify if:

• Patients with isolated TBI requiring surgery
• Surgery performed within 48 hours after insult

You may not qualify if:

• Presence of extracranial injuries (such as but not limited to orthopedic/ chest/ cardiac/ abdominal/ pelvis)
• Penetrating craniocerebral injury
• Pregnancy

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Bharath Srinivasaiah, MD

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: June 25, 2018
• Study Start: December 5, 2015
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)