Hypothermia for Pediatric Cardiac Arrest Planning Grant

低体温儿童心脏骤停计划补助金

• 批准号: 6781780
• 负责人: FRANK W MOLER
• 金额: $ 15.3万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-24 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6781780
• 关键词: apnea; cardiovascular disorder epidemiology; clinical research; disease /disorder etiology; heart arrest; human data; human subject; human therapy evaluation; induced hypothermia; outcomes research; patient oriented research; pediatrics

DESCRIPTION (provided by the applicant): Cardiopulmonary arrest with apnea and loss of palpable pulse (CA) in childhood is a tragic event that very often results in either death or poor quality long-term neurological survival. Recent randomized clinical trials (RCT) in adult populations have reported improved neurologic outcome and survival in groups that received short term mild hypothermia following out of hospital ventricular fibrillation (VF) arrest. The efficacy of hypothermia in children following cardiac arrest is not known. CA in children is commonly secondary to a respiratory etiology that results in hypoxia, which after a period of time results in cardiac arrest. Asystole or pulseless electrical activity are the most common presenting cardiac rhythms when resuscitation is initiated. In adults by contrast, a sudden cardiac event (without a preceding period of hypoxia) most often occurs with VF or ventricular tachycardia, the common presenting rhythms. In this clinical trial planning grant application, 15 Pediatric Emergency Care Applied Research Network (PECARN) children's hospitals with intensive care units will obtain pilot data from the medical records of patients who have sustained a CA with return of spontaneous circulation in either the outpatient or inpatient setting. Characterization of this population will include arrest specific events and etiology, patient characteristics, hospital course, interventions received, hospital survival, and neurologic outcome. This information will be used to create inclusion and exclusion criteria, and to calculate sample size requirements for a future RCT of hypothermia following pediatric cardiac arrest. Duration of time to successfully enroll patients from this cohort of 15 children's hospitals for a future RCT will be estimated. This application will also result in creation of multiple documents needed to perform a RCT of hypothermia after cardiac arrest in childhood including study related data forms, study protocols, manuals of operation, institutional review board and informed consent related documents, and other materials. The PECARN will support all phases of this application with its existing clinical trials research infrastructure that includes a steering committee, five clinical trials supporting subcommittees, and a central data management coordinating center (CDMCC). The CDMCC will make operational all data and analysis related tasks of this application, and assure all study sites are compliant with regulations concerning data security and confidentiality.

描述（由申请人提供）：儿童期心脏骤停伴呼吸暂停和可触及脉搏（CA）丧失是一种悲惨事件，通常导致死亡或长期神经系统生存质量差。最近在成人人群中进行的随机临床试验（RCT）报告称，在院外室颤（VF）停搏后接受短期轻度低温治疗的组中，神经学结局和生存率得到改善。儿童心脏骤停后低温治疗的效果尚不清楚。儿童CA通常继发于导致缺氧的呼吸道病因，一段时间后导致心脏骤停。心搏停止或无脉性电活动是复苏开始时最常见的心律。相比之下，在成人中，突发心脏事件（没有先前的缺氧期）最常发生VF或室性心动过速，这是常见的表现节律。在这项临床试验计划拨款申请中，15家设有重症监护室的儿科急诊应用研究网络（PECARN）儿童医院将从门诊或住院患者中持续CA并恢复自主循环的患者的病历中获得试点数据。该人群的特征将包括心脏骤停特定事件和病因、患者特征、住院病程、接受的干预、住院生存期和神经学结局。该信息将用于创建入选和排除标准，并计算未来儿科心脏骤停后体温过低RCT的样本量要求。将估计从该队列的15家儿童医院成功招募患者进行未来RCT的持续时间。该应用程序还将创建执行儿童心脏骤停后低体温RCT所需的多个文件，包括研究相关数据表、研究方案、操作手册、机构审查委员会和知情同意相关文件以及其他材料。PECARN将通过其现有的临床试验研究基础设施支持该申请的所有阶段，其中包括指导委员会，五个临床试验支持小组委员会和一个中央数据管理协调中心（CDMCC）。CDMCC将执行本申请的所有数据和分析相关任务，并确保所有研究中心遵守有关数据安全和保密的法规。

项目成果

Multicenter cohort study of out-of-hospital pediatric cardiac arrest.

• DOI: 10.1097/ccm.0b013e3181fa3c17
• 发表时间: 2011-01
• 期刊: Critical care medicine
• 影响因子: 8.8
• 作者: Moler FW;Donaldson AE;Meert K;Brilli RJ;Nadkarni V;Shaffner DH;Schleien CL;Clark RS;Dalton HJ;Statler K;Tieves KS;Hackbarth R;Pretzlaff R;van der Jagt EW;Pineda J;Hernan L;Dean JM;Pediatric Emergency Care Applied Research Network
• 通讯作者: Pediatric Emergency Care Applied Research Network

Multicenter cohort study of in-hospital pediatric cardiac arrest.

• DOI: 10.1097/pcc.0b013e3181a7045c
• 发表时间: 2009-09
• 期刊: Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
• 作者: Meert KL;Donaldson A;Nadkarni V;Tieves KS;Schleien CL;Brilli RJ;Clark RS;Shaffner DH;Levy F;Statler K;Dalton HJ;van der Jagt EW;Hackbarth R;Pretzlaff R;Hernan L;Dean JM;Moler FW;Pediatric Emergency Care Applied Research Network
• 通讯作者: Pediatric Emergency Care Applied Research Network