Cardiac Dysfunction in Traumatic Brain Injury

NCT ID: NCT03566368

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-05
• Study Completion Date: 2018-01-15

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.

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.

Conditions

Trauma, Head; Cardiac Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

Isolated Traumatic Brain Injury Patients requiring emergency surgical intervention.

Electrocardiogram

Intervention Type: DIAGNOSTIC_TEST

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

Transthoracic Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Electrocardiogram

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

Intervention Type: DIAGNOSTIC_TEST

Transthoracic Echocardiogram

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

Intervention Type: DIAGNOSTIC_TEST

Cardiac enzyme - Troponin I Levels

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ECG; ECHO; TROP-I

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

S. Bharath

Senior Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bharath Srinivasaiah, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuro Sciences, India

Locations

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 23963125 (View on PubMed)

Other Identifiers

III, 3.02 Neurosciences

Identifier Type: -

Identifier Source: org_study_id