Mild Hypothermia for Resuscitated Out-of-Hospital Cardiac Arrest Patients

院外心脏骤停复苏患者的轻度低温治疗

• 批准号: 7459480
• 负责人: Francis Kim
• 金额: $ 72.35万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-08 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7459480
• 关键词: Accident and Emergency department; Admission activity; American Heart Association; Animal Model; Applications Grants; Area; Blood Circulation; Brain Injuries; Caring; Catheters; Coma; Conscious; Data; Drops; Emergency Situation; End Point; Goals; Guidelines; Heart Arrest; Heating; Helmet; Hospital Records; Hospitals; Ice; Infusion procedures; Intervention; Interview; Medical; Morbidity - disease rate; Muscle; Neurologic; Normal saline; Numbers; Outcome; Paralysed; Paramedical Personnel; Patients; Placement; Population; Protocols documentation; Public Health; Publishing; Randomized; Randomized Controlled Clinical Trials; Recovery; Reporting; Running; Safety; Sample Size; Sedation procedure; Side; Solutions; Standards of Weights and Measures; System; Techniques; Telephone; Temperature; United States; Ventricular Fibrillation; awake; base; cold temperature; comparison group; experience; follow-up; improved; induced hypothermia; intravenous administration; mortality; natural hypothermia; sudden cardiac death

DESCRIPTION (provided by applicant): Between 400,000 and 450,000 people are estimated to experience sudden cardiac death out of hospital or in the emergency room each year in the United States. Brain damage is a major cause of morbidity and mortality in these patients with most never regaining consciousness. Safe and effective therapies that improve outcome after cardiac arrest are urgently needed. Even with delays of 4 to 8 h to achieve target temperatures, induced mild hypothermia (32-34:C) in patients resuscitated from out-of-hospital ventricular fibrillation (VF) improved neurologic recovery and survival. Despite this evidence, induced hypothermia is not widely used, and its efficacy in patients with other initial rhythms is largely unstudied. Results from animal models suggest that efficacy of mild hypothermia would improve if initiated as soon as possible after return of spontaneous circulation (ROSC). The overall goal of this study is to determine whether a strategy of field cooling improves outcome after out-of-hospital cardiac arrest. To this end, we will randomize 1364 eligible (achieving ROSC but still comatose) patients with treated out-of-hospital for cardiac arrest (both VF and non-VF) to standard care with or without field cooling initiated immediately by paramedics following ROSC. Field cooling will be achieved with intravenous infusion of 2 liters of 4:C normal saline over 20 to 30 minutes, sedation, and muscle paralysis. Outcome will be based on the endpoint: 'awake at hospital discharge'. Since hospital cooling could potentially modify or confound the effect of field cooling, both randomization and analysis will be stratified by whether or not the intended receiving hospital has a routine cooling protocol. Because of the American Heart Association (AHA) guidelines, most hospitals in the study area routinely cool comatose patients with ROSC whose initial rhythm was VF. Such hospitals do not generally cool similar patients whose initial rhythm was not VF, though this is somewhat variable. A few hospitals do not cool. Data will be collected from review of paramedic run reports, hospital records, and 3- month telephone follow-up interview. We propose the following specific aims: Aim 1: Determine outcome of field cooling in eligible patients whose initial rhythm is VF and intended to be delivered to a cooling hospital. Aim 2: Examine safety of field cooling in eligible patients whose initial rhythm is not VF, i.e., pulseless electrical activity or asystole Aim 3: Compare the outcome differences in VF patients delivered to non-cooling hospitals with the differences found in the primary comparison population, VF patients delivered to cooling hospitals. PUBLIC HEALTH RELEVANCE: Between 400,000 and 450,000 people are estimated to experience sudden cardiac death out of hospital or in the emergency room each year in the United States. Brain damage is a major cause of morbidity and mortality in these patients with most never regaining consciousness. Safe and effective therapies that improve outcome after cardiac arrest are urgently needed and in this grant proposal we aim to determine whether the application of mild hypothermia using a rapid infusion of cold normal saline will improve outcome in patients who suffer out-of-hospital cardiac arrest.

描述（由申请人提供）：据估计，美国每年有 400,000 至 450,000 人在医院外或急诊室发生心源性猝死。脑损伤是这些患者发病和死亡的主要原因，大多数患者从未恢复意识。迫切需要安全有效的治疗方法来改善心脏骤停后的预后。即使延迟 4 至 8 小时才能达到目标温度，在院外心室颤动 (VF) 复苏的患者中诱导轻度低温 (32-34:C) 也能改善神经功能恢复和生存。尽管有这些证据，诱导低温疗法并未广泛使用，其对具有其他初始节律的患者的疗效在很大程度上尚未得到研究。动物模型的结果表明，如果在自主循环（ROSC）恢复后尽快开始亚低温治疗，其疗效将会提高。本研究的总体目标是确定现场冷却策略是否可以改善院外心脏骤停后的预后。为此，我们将随机将 1364 名因心脏骤停（心室颤动和非心室颤动）而接受院外治疗的合格患者（达到 ROSC 但仍处于昏迷状态）接受标准护理，无论是否由护理人员在 ROSC 后立即启动现场降温。通过静脉输注 2 升 4:C 生理盐水 20 至 30 分钟、镇静和肌肉麻痹来实现现场降温。结果将基于终点：“出院时清醒”。由于医院降温可能会改变或混淆现场降温的效果，因此随机化和分析都将根据预期接收医院是否有常规降温方案进行分层。根据美国心脏协会 (AHA) 的指导方针，研究地区的大多数医院都会对初始心律为室颤的 ROSC 昏迷患者进行常规降温。这些医院一般不会对初始心律不是心室颤动的类似患者进行冷却，尽管这有些变化。少数医院不降温。数据将通过护理人员运行报告、医院记录和 3 个月电话随访访谈的审查来收集。我们提出以下具体目标： 目标 1：确定初始节律为室颤并打算送往降温医院的合格患者的现场降温效果。目标 2：检查初始节律不是室颤（即无脉电活动或心搏停止）的合格患者的现场降温安全性。 目标 3：将送往非降温医院的室颤患者的结果差异与主要比较人群（送往降温医院的室颤患者）中发现的结果差异进行比较。公共卫生相关性：据估计，美国每年有 400,000 至 450,000 人在医院外或急诊室发生心源性猝死。脑损伤是这些患者发病和死亡的主要原因，大多数患者从未恢复意识。迫切需要改善心脏骤停后预后的安全有效的治疗方法，在这项拨款提案中，我们的目标是确定使用快速输注冷生理盐水进行亚低温治疗是否会改善院外心脏骤停患者的预后。