Cardiac Dysfunction in Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Trauma, Head, Cardiac Complication

Intervention / Treatment
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* Diagnostic Test: Electrocardiogram
* Diagnostic Test: Transthoracic Echocardiogram
* Diagnostic Test: Cardiac enzyme - Troponin I Levels


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Isolated Traumatic Brain Injury Patients requiring emergency surgical intervention. | Diagnostic Test: Electrocardiogram<br>* a 12 lead surface electrocardiogram taken after connecting limb and chest electrodes<br>* Other names: ECG;Diagnostic Test: Transthoracic Echocardiogram<br>* Transthoracic echocardiogram performed to evaluate Cardiac function in parasternal - long and short axis, Apical - 4 chamber and 5 chamber views.<br>* Other names: ECHO;Diagnostic Test: Cardiac enzyme - Troponin I Levels<br>* Blood sample - venous collected to measure blood troponin - I levels.<br>* Other names: TROP-I;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Dysfunction, Traumatic Brain Injury