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: 7899796
• 负责人: Francis Kim
• 金额: $ 73.82万
• 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/7899796
• 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; 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; public health relevance; 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)：据估计，在美国，每年有400,000至45,000人在医院外或在急诊室经历心脏性猝死。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4~8h才能达到目标体温，对院外室颤(VF)复苏的患者诱导亚低温(32~34：C)仍能改善神经功能恢复和生存。尽管有这些证据，诱导降温并没有被广泛使用，它对有其他初始节律的患者的疗效在很大程度上还没有研究。动物模型的结果表明，如果在自主循环恢复(ROSC)后尽快开始亚低温治疗，疗效将会提高。这项研究的总体目标是确定野外降温策略是否能改善院外心脏骤停后的预后。为此，我们将1364名符合条件的(达到ROSC但仍处于昏迷状态)因心脏骤停(包括室颤和非室颤)而在院外接受治疗的患者随机分为标准护理组，由护理人员在ROSC后立即开始现场降温或不现场降温。现场降温的方法是静脉输注2升4：C生理盐水，持续20到30分钟，出现镇静和肌肉瘫痪。结果将基于终点：“出院时清醒”。由于医院降温可能会潜在地改变或混淆现场降温的效果，随机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。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地对初始心律为室颤的ROSC昏迷患者进行降温。这类医院通常不会冷却最初心律不是室颤的相似患者，尽管这在某种程度上是可变的。一些医院对此并不感冒。数据将通过审查护理人员的运行报告、医院记录和为期3个月的电话随访而收集。我们提出了以下具体目标：目标1：确定初始心律为室颤并打算送往降温医院的符合条件的患者的现场降温结果。目的2：检查符合条件的非室性心动过速患者现场降温的安全性。目的3：比较送往非降温医院的VF患者与送入降温医院的VF患者的主要对照人群的结局差异。与公共卫生相关：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，其中大多数患者从未恢复意识。迫切需要安全和有效的治疗方法来改善心脏骤停后的预后，在这项赠款提案中，我们的目标是确定使用冷生理盐水快速输注的亚低温是否会改善院外心脏骤停患者的预后。