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）：据估计，每年在美国，估计有40万至450,000人在医院或急诊室经历突然的心脏死亡。在这些患者中，脑损伤是造成发病率和死亡率的主要原因，这些患者大多数从未恢复过意识。紧急需要急需改善心脏骤停后预后的安全有效疗法。即使延迟4至8小时以达到目标温度，也因院外心室纤维化（VF）复苏的患者诱发了轻度体温过低（32-34：C），改善了神经系统恢复和生存。尽管有这些证据，但诱发的体温过低并未被广泛使用，并且其在其他初始节奏的患者中的功效在很大程度上尚未研究。动物模型的结果表明，如果自发循环（ROSC）尽快启动，轻度体温过低的功效将提高。这项研究的总体目的是确定院外心脏骤停后的野外冷却策略是否可以改善结果。为此，我们将将1364个合格的1364条符合条件（即将达到ROSC但仍昏迷）患者患有心脏骤停（VF和非VF）的患者，以进行标准护理，并在ROSC后立即由护理人员立即由护理人员立即引发或没有现场冷却。静脉输注2升4：C正常盐水在20至30分钟内，镇静和肌肉麻痹，将实现现场冷却。结果将基于终点：“出院时醒着”。由于医院冷却可能会改变或混淆场冷却的影响，因此随机化和分析都将通过预期的接收医院是否具有常规冷却方案来分层。由于制定了美国心脏协会（AHA）的指南，研究区域中的大多数医院通常会与最初的节奏为VF的ROSC昏迷患者。这样的医院通常不会使初始节奏不是VF的类似患者冷静，尽管这有些可变。一些医院不酷。数据将从护理人员运行报告，医院记录和3个月的电话随访访谈中收集。我们提出以下具体目标：目标1：确定最初节奏为VF且打算交付给冷却医院的合格患者的场冷却结果。 AIM 2：检查最初的节奏不是VF的合格患者的现场冷却的安全性，即无脉冲的电活动或障碍AIM 3：比较送到非冷却医院的VF患者的结果差异与主要比较人群中发现的差异，VF患者分娩给冷却医院。公共卫生相关性：据估计，每年在美国，估计有40万至450,000人在医院或急诊室遭受突然的心脏死亡。在这些患者中，脑损伤是造成发病率和死亡率的主要原因，这些患者大多数从未恢复过意识。紧急需要急需改善心脏骤停后预后的安全有效疗法，在这项赠款建议中，我们旨在确定使用快速输注冷盐水的轻度体温过低是否会改善遭受院外心脏骤停的患者的预后。