Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT03566368
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2018-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Dysfunction in Traumatic Brain Injury
Sponsor:
National Institute of Mental Health and Neuro Sciences, India
Organization:
Study Overview
Official Title:
Incidence and Impact of Cardiac Dysfunction in Isolated Traumatic Brain Injury Patients Requiring Surgical Intervention
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: