Cardiac Dysfunction in Traumatic Brain Injury

Incidence and Impact of Cardiac Dysfunction in Isolated Traumatic Brain Injury Patients Requiring Surgical Intervention

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Complication; Trauma, Head
• Intervention / Treatment: Diagnostic test: Electrocardiogram; Diagnostic test: Transthoracic Echocardiogram; Diagnostic test: Cardiac enzyme - Troponin I Levels

Detailed Description

Traumatic brain injury (TBI) is a major public health concern and a leading cause of traumatic death worldwide. It contributes to significant mortality, morbidity and economic costs. TBI along with secondary insults have been associated with worse neurologic and clinical outcomes. Post-TBI hypotension (systolic blood pressure <90 mmHg) has been directly linked to mortality. Cardiac dysfunction has been documented in TBI and implicated as a cause for hypotensive episode during TBI surgery. However in majority of the situations, the cause is often unknown, and the treatment is empiric.

Abnormal electrocardiographic (ECG) findings are associated with various neurologic hemorrhages which includes TBI, where both ischemic-like changes and a variety of repolarization abnormalities have been described. These changes are thought to be secondary to sympathetic over-activity and autonomic imbalance, and are associated with dysfunction documented by transthoracic echocardiography and cardiac enzyme elevations. Despite the frequency with which TBI affects the general population and the high prevalence of secondary end-organ dysfunction after TBI, its potential impact on cardiac function has received little attention outside of case reports, small case series & retrospective studies. In our study, we intend to evaluate the incidence and impact of cardiac dysfunction on neurological outcomes in TBI.

Methodology: The proposed study is prospective and observational. After obtaining informed consent, Adult traumatic brain injury patients posted for surgery are recruited. Preoperatively patient's demographic and clinical parameters are recorded.Patient management are according to insitutional practice in lines with Brain Trauma Foundation guidelines. ECG, transthoracic ECHO and blood levels for Troponin I are tested. Intraoperatively, patient's hemodynamics are monitored with EV1000- FLOTRAC sensor using a Radial arterial and central venous line conitnuously and important time points during surgery are noted. Intraoperative drugs, fluids and any events are noted. In the postoperative period, the same physiological parameters including ECG, ECHO and Trop I are recorded for 7 days starting from the day of surgery.

The result from this study will help us understand the nature and the severity of cardiac dysfunction in head injured Indian patients requiring surgery. This will help us in improving our current practices of perioperative management and minimize secondary insults during the patients hospital stay resulting in better neurological outcome.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560029
      • National Institute of Mental Health and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Group; Isolated Traumatic Brain Injury Patients requiring emergency surgical intervention.

Diagnostic test: Electrocardiogram; a 12 lead surface electrocardiogram taken after connecting limb and chest electrodes; Other Names: ECG; Diagnostic test: Transthoracic Echocardiogram; Transthoracic echocardiogram performed to evaluate Cardiac function in parasternal - long and short axis, Apical - 4 chamber and 5 chamber views.; Other Names: ECHO; Diagnostic test: Cardiac enzyme - Troponin I Levels; Blood sample - venous collected to measure blood troponin - I levels.; Other Names: TROP-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG abnormality - Tachycardia	ECG - heart rate > 100 min	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	ECG - heart rate < 60/ min	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	ECG - Prolonged PR Interval >200 ms	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	ECG - Prolonged QRS duration >120 ms	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	ECG - ST segment elevation and depression ≥0.1 mV in limb leads and ≥0.2 mV in chest leads, inverted (negative) T wave in any lead apart from aVR and V1	Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
ECG abnormality - Morphological End Repolarization abnormalities	ECG - T-wave showing biphasic, 2-peaked or separated U wave ≥0.1 mV	Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
Elevated Cardiac Enzyme Levels	TROP I levels tested by i-STAT cTnI method on i-STAT device (Abbott Diagnostics, Abbott Park, IL) > 0.1 ng/mL.	Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
Short Term neurological outcome	Glasgow coma score (3-15) recorded at bedside.	Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7, At 1 month.
Hemodynamic Parameter - Cardiac Index	Cardiac Index values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Hemodynamic Parameter - Stroke volume index	Stroke volume index values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Hemodynamic parameter - Heart Rate	Heart rate values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Hemodynamic parameter - Mean Arterial Pressure	Mean Arterial Pressure values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Hemodynamic parameter - Stroke Volume Variation	Stroke Volume Variation values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Hemodynamic parameter - Systemic Vascular Resistance Index	Systemic Vascular Resistance Index values obtained from FloTrac transducer (FloTracTM, Edwards Lifesciences, Irvine, CA, USA) was used to connect the arterial line to the EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).	Continuous Values at 1 Min interval throughout the intraoperative period.
Long term neurological outcome	Extended Glasgow Outcome score (1-8)	At 3 Months, At 6 months, At 1 year.
Hospital Stay	Total number of days in hospital from admission to discharge	At 1 month

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India
• Investigators: Principal Investigator: Bharath Srinivasaiah, MD, National Institute of Mental Health and Neuro Sciences, India

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2015
• Primary Completion (ACTUAL): January 15, 2017
• Study Completion (ACTUAL): January 15, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (ACTUAL): June 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Cardiac Dysfunction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: III, 3.02 Neurosciences

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No