Cardiac Dysfunction in Traumatic Brain Injury

Cardiac Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566368
• Other study ID #: III, 3.02 Neurosciences
• Status: Completed
• Start date: December 5, 2015
• Est. completion date: January 15, 2018

Study information

• Verified date: June 2018
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cardiac Complication
• Craniocerebral Trauma
• Trauma, Head

Intervention

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

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciences	Bengaluru	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Long term neurological outcome	Extended Glasgow Outcome score (1-8)	At 3 Months, At 6 months, At 1 year.
Secondary	Hospital Stay	Total number of days in hospital from admission to discharge	At 1 month

External Links

•   Institute web with details of submitted desertations, can also be obtained through contact Neuroanesthesiolgy department - Dr UmaMaheshwara Rao