Cardiac Dysfunction in Traumatic Brain Injury

只有注册用户可以翻译文章

登陆注册

链接已保存到剪贴板

状态已完成

赞助商

National Institute of Mental Health and Neuro Sciences, India

临床试验: NCT03566368

BioSeek: NCT03566368

关键词

抽象

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.

描述

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.

日期

最后验证:	05/31/2018
首次提交:	04/18/2018
提交的预估入学人数:	06/19/2018
首次发布:	06/24/2018
上次提交的更新:	06/19/2018
最近更新发布:	06/24/2018
实际学习开始日期:	12/04/2015
预计主要完成日期:	01/14/2017
预计完成日期:	01/14/2018

状况或疾病

Trauma, Head

Cardiac Complication

干预/治疗

Diagnostic Test: Study Group

相

手臂组

臂	干预/治疗
Study Group Isolated Traumatic Brain Injury Patients requiring emergency surgical intervention.	Diagnostic Test: Study Group a 12 lead surface electrocardiogram taken after connecting limb and chest electrodes

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
取样方式	Non-Probability Sample
接受健康志愿者	是
标准	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

结果

主要结果指标

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

次要成果指标

1. ECG abnormality - Tachycardia [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [At 3 Months, At 6 months, At 1 year.]

Extended Glasgow Outcome score (1-8)

16. Hospital Stay [At 1 month]

Total number of days in hospital from admission to discharge

Cardiac Dysfunction in Traumatic Brain Injury

关键词

hemorrhage

hypotension

抽象

描述

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

科学支持的最完整的草药数据库