Clinical trial NCT03566368: Cardiac Dysfunction in Traumatic Brain Injury
Official title: Incidence and Impact of Cardiac Dysfunction in Isolated Traumatic Brain Injury Patients Requiring Surgical Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Head
Cardiac Complication
Keywords: Cardiac Dysfunction
Traumatic Brain Injury
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of Left Ventricular Ejection Fraction < 50% and change following surgery
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: Incidence of Left ventricular regional wall motion abnormality and change following surgery
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
Secondary outcomes:
measure: ECG abnormality - Tachycardia
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: ECG abnormality - Bradycardia
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: ECG abnormaltiy - Prolonged PR interval
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: ECG abnormality - Prolonged QRS duration
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: ECG abnormality - ST-T changes
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: ECG abnormality - Morphological End Repolarization abnormalities
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: Elevated Cardiac Enzyme Levels
timeFrame: Preoperative, Postoperative day 1, Postoperative day 2, Postoperative day 3, Postoperative day 4, Postoperative day 5, Postoperative day 6, Postoperative day 7.
measure: Short Term neurological outcome
timeFrame: 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.
measure: Hemodynamic Parameter - Cardiac Index
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Hemodynamic Parameter - Stroke volume index
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Hemodynamic parameter - Heart Rate
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Hemodynamic parameter - Mean Arterial Pressure
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Hemodynamic parameter - Stroke Volume Variation
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Hemodynamic parameter - Systemic Vascular Resistance Index
timeFrame: Continuous Values at 1 Min interval throughout the intraoperative period.
measure: Long term neurological outcome
timeFrame: At 3 Months, At 6 months, At 1 year.
measure: Hospital Stay
timeFrame: At 1 month
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: National Institute of Mental Health and Neurosciences
state: Karnataka
Study officials:
affiliation: National Institute of Mental Health and Neuro Sciences, India
name: Bharath Srinivasaiah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.