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Completed

NCT Number: NCT03566368

Cardiac Dysfunction in Traumatic Brain Injury

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocardiogram

Diagnostic Test

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

Other names: ECG

Transthoracic Echocardiogram

Diagnostic Test

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

Other names: ECHO

Cardiac enzyme - Troponin I Levels

Diagnostic Test

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

Other names: TROP-I

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

  1. ECG abnormality - Tachycardia

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

    ECG - heart rate > 100 min

  2. ECG abnormality - Bradycardia

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

    ECG - heart rate < 60/ min

  3. ECG abnormaltiy - Prolonged PR interval

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

    ECG - Prolonged PR Interval >200 ms

  4. ECG abnormality - Prolonged QRS duration

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

    ECG - Prolonged QRS duration >120 ms

  5. ECG abnormality - ST-T changes

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

    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

  6. ECG abnormality - Morphological End Repolarization abnormalities

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

    ECG - T-wave showing biphasic, 2-peaked or separated U wave ≥0.1 mV

  7. Elevated Cardiac Enzyme Levels

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

    TROP I levels tested by i-STAT cTnI method on i-STAT device (Abbott Diagnostics, Abbott Park, IL) > 0.1 ng/mL.

  8. Short Term neurological outcome

    Time frame: 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.

    Glasgow coma score (3-15) recorded at bedside.

  9. Hemodynamic Parameter - Cardiac Index

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  10. Hemodynamic Parameter - Stroke volume index

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  11. Hemodynamic parameter - Heart Rate

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  12. Hemodynamic parameter - Mean Arterial Pressure

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  13. Hemodynamic parameter - Stroke Volume Variation

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  14. Hemodynamic parameter - Systemic Vascular Resistance Index

    Time frame: Continuous Values at 1 Min interval throughout the intraoperative period.

    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).

  15. Long term neurological outcome

    Time frame: At 3 Months, At 6 months, At 1 year.

    Extended Glasgow Outcome score (1-8)

  16. Hospital Stay

    Time frame: At 1 month

    Total number of days in hospital from admission to discharge

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 25, 2018
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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