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: 8097237
• 负责人: Francis Kim
• 金额: $ 74.38万
• 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/8097237
• 关键词: Accident and Emergency department; Admission activity; American Heart Association; Animal Model; Applications Grants; Area; Blood Circulation; Brain Injuries; Catheters; Coma; Conscious; Data; Drops; Emergency Situation; Goals; Guidelines; Health; Heart Arrest; Heating; Helmet; Hospital Records; Hospitals; Ice; Infusion procedures; Intervention; Interview; Intravenous infusion procedures; Medical; Morbidity - disease rate; Muscle; Neurologic; Normal saline; Outcome; Paralysed; Paramedical Personnel; Patients; Population; Protocols documentation; Publishing; Randomized; Recovery; Reporting; Running; Safety; Sample Size; Sedation procedure; Side; Solutions; System; Techniques; Telephone; Temperature; United States; Ventricular Fibrillation; awake; base; cold temperature; comparison group; effective therapy; experience; follow-up; improved; induced hypothermia; mortality; natural hypothermia; randomized trial; standard care; 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）：在美国，估计每年有400，000至450，000人在医院外或急诊室中发生心脏性猝死。脑损伤是这些患者发病和死亡的主要原因，其中大多数从未恢复意识。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小时达到目标温度，在院外室颤（VF）复苏的患者中诱导轻度低温（32-34：C）也可改善神经功能恢复和生存。尽管有这样的证据，诱导低温并没有被广泛使用，其在其他初始节律患者中的疗效在很大程度上未经研究。动物模型的结果表明，如果在自主循环恢复（ROSC）后尽快开始，亚低温的疗效将得到改善。本研究的总体目标是确定场冷却策略是否改善院外心脏骤停后的结局。为此，我们将1364例合格（达到ROSC但仍昏迷）的因心脏骤停（VF和非VF）接受院外治疗的患者随机分配至标准治疗组，在ROSC后由护理人员立即启动或不启动现场冷却。在20至30分钟内静脉输注2升4：C生理盐水、镇静和肌肉麻痹，以实现现场冷却。结局将基于终点：“出院时清醒”。由于医院冷却可能会改变或混淆现场冷却的效果，因此将根据预期接收医院是否具有常规冷却方案对随机化和分析进行分层。由于美国心脏协会（AHA）的指导方针，研究地区的大多数医院常规冷却昏迷患者与ROSC的初始心律是VF。此类医院通常不会冷却初始心律不是VF的类似患者，尽管这在某种程度上是可变的。几家医院不降温。将通过审查护理人员运行报告、医院记录和3个月电话随访访视收集数据。我们提出了以下具体目标：目标1：确定初始心律为VF且预期输送至冷却医院的合格患者的场冷却结果。目的2：检查初始心律不是VF的合格患者的场冷却安全性，即，无脉性电活动或心搏停止目的3：比较被送到非冷却医院的VF患者的结果差异与在主要比较人群（被送到冷却医院的VF患者）中发现的差异。公共卫生相关性：据估计，在美国，每年有40万至45万人在医院外或急诊室发生心脏性猝死。脑损伤是这些患者发病和死亡的主要原因，其中大多数从未恢复意识。安全有效的治疗，改善心脏骤停后的结果是迫切需要的，在这个赠款提案中，我们的目标是确定是否使用冷生理盐水快速输注轻度低温的应用将改善谁遭受院外心脏骤停的患者的结果。