Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
研究概览
简要总结
Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP.
The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation with a Glasgow Coma Scale ≤ 8/15 after in- or out-of-hospital cardiac arrest
- •Mean arterial pressure between 65 and 85 mmHg with or without vasopressor support
排除标准
- •Age < 18 years old
- •No flow (time between cardiac arrest and the beginning of cardiac massage) > 15 minutes or unknown
- •Low flow ((time between cardiac arrest and ROSC: return of spontaneous circulation)> 60 minutes
- •Time between ROSC and inclusion > 12 hours
- •Transcranial doppler unavailable
- •Cardiac arrythmia
- •Patient under extracorporeal life support before inclusion or at risk of being referred for assistance due to cardiogenic shock with high dose of vasopressors before inclusion (MAP < 65 mmHg with norepinephrine or epinephrine > 1 µg/kg/min or dobutamine > 10 µg/kg/min)
- •Severe cardiac dysfunction defined by left ventricular ejection fraction < 20% or aortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) < 14 cm with dobutamine > 10µg/kg/min
- •Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Distress Syndrome (ARDS) before inclusion
- •Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage or traumatic brain injury
- •Hemorrhagic shock
- •Any acute pathology that requires strict blood pressure control (aortic dissection, stroke, cardiogenic pulmonary edema with high blood pressure)
- •Decision of withdrawing or withholding life sustaining treatment before inclusion or considered during the first 12 hours of ICU management
- •Patient with a modified Rankin scale (MRS) 4 or 5 prior to resuscitation
- •Pregnancy or lactation
- •Patients already enrolled in another clinical study on cardiac arrest
- •Patients with judicial protection
- •No social security coverage
结局指标
主要结局
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
时间窗: In the first hour after inclusion
Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.
次要结局
- Cerebral oxygenation modifications induced by increasing MAP(At the 6th, 12th, 24th, 48th and 72nd hour after inclusion)
- 28 day survival(28 days after inclusion)
- Cerebral blood flow modifications induced by increasing MAP(At the 6th, 12th, 24th, 48th and 72nd hour after inclusion)
- Measure of the degree of disability in the activities of daily living of the included patients(90 days after inclusion)
- Undesirable events induced by increasing MAP(At the 72nd hour after inclusion)
- Plasmatic concentrations of Neuron Specific Enolase(At the 72nd hour after inclusion)
- 90 days survival(90 days after inclusion)