2/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

2/2 儿童冷却时间对心脏骤停患者疗效的影响 (P-ICECAP)

• 批准号: 10283668
• 负责人: Sharon Dziuba Yeatts
• 金额: $ 66.03万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10283668
• 关键词: Accident and Emergency department; Adaptive Behaviors; Address; Adult; Adverse event; Asphyxia Neonatorum; Biostatistics Core; Brain; Brain Injuries; Cardiopulmonary Arrest; Case Report Form; Cessation of life; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Collection; Coma; Common Data Element; Companions; Coupled; Data; Data Coordinating Center; Data Set; Databases; Development; Devices; Emergency Care; Evaluation; Event; FDA approved; Fever; Goals; Guidelines; Health Sciences; Heart Arrest; Hospitals; Impairment; International; Investments; Knowledge; Left; Manuscripts; Medical; Methods; Michigan; Modeling; Monitor; Multi-site clinical study; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Newborn Infant; Online Systems; Outcome; Patient Selection; Patients; Periodicity; Population; Procedures; Protocols documentation; Public Health; Publications; Quality of life; Randomized; Recovery; Reporting; Research; Research Design; Research Priority; Resources; Resuscitation; Risk; Role; Safety; Selection Criteria; South Carolina; Specific qualifier value; Survivors; System; Temperature; Therapeutic; Time; United States National Institutes of Health; Universities; Utah; Work; age group; base; cerebral ischemic injury; clinical investigation; clinical practice; clinical research site; data management; data quality; design; disability; electronic data; experience; implementation facilitation; improved; improved outcome; innovation; method development; mortality; natural hypothermia; neonate; neurobehavioral; neurological recovery; novel; organizational structure; out-of-hospital cardiac arrest; pre-clinical; preference; prevent; response; treatment effect; trend; trial design

Project Summary Out-of-hospital cardiac arrest (OHCA) in children is a tragic event that usually results in death or permanent brain injury in survivors. More than 7000 children suffer OHCA each year in the US and improvements in pediatric OHCA outcomes, just as in adults, is very much limited by our ability to protect the brain from global cerebral ischemic injury in those who are successfully resuscitated. Targeted temperature management (TTM) is currently guideline-recommended in children following OHCA with preference stated for therapeutic hypothermia (TTM 32-34°C) over normothermia (TTM 36-37.5°C) in order to prevent fever which could amplify brain injury. The optimal duration and patient selection criteria for therapeutic hypothermia in children remain unknown and cooling devices are not specifically FDA approved for this indication. Preclinical data and mechanistic studies strongly suggest that durations of hypothermia longer than those typically used in adults may minimize brain injury. This study will determine if identifying an optimal duration (dose) of therapeutic hypothermia can improve outcomes, and if development of a duration response curve can confirm efficacy in a wider pediatric population of OHCA survivors. We hypothesize that longer durations of cooling will improve survival and result in better neurologic recovery in survivors compared to shorter cooling durations, as assessed by the Vineland Adaptive Behavior Scales–Third Edition (Vineland-3) score. The primary goal of this project is to identify clinical strategies that will increase the number of patients with improved neurological recovery from OHCA. The results of this trial will be extremely significant in children and will immediately impact both clinical practice and regulatory evaluation. The Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) trial, modeled after the ongoing adult ICECAP trial, uses innovative adaptive dose finding methods that allow exploration of a wide range of potential durations and efficiently allocate subjects where they will be most informative. The study will be conducted using resources of the NHLBI/NINDS Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), which is experienced in both pediatric and adult trials, and is currently conducting the current adult ICECAP Trial. SIREN leverages existing resources to achieve economies of scale and to conduct important clinical investigations spanning from pre-hospital, through both the emergency department and ICU stay, and post hospital discharge.

项目摘要 儿童院外心脏骤停（OHCA）是一种悲惨的事件，通常会导致死亡或永久性死亡。 幸存者的脑损伤在美国，每年有7000多名儿童患有OHCA， 儿童OHCA的结果，就像成人一样，受到我们保护大脑免受全球性疾病的能力的限制。 脑缺血性损伤的那些成功复苏。目标温度管理（TTM） 目前指南推荐OHCA后的儿童使用，首选治疗药物 体温过低（TTM 32-34°C）超过正常体温（TTM 36-37.5°C），以防止发热， 脑损伤儿童低温治疗的最佳持续时间和患者选择标准仍然存在 未知和冷却装置未专门获得FDA批准用于该适应症。临床前数据和 机械研究强烈表明，低温持续时间长于成人通常使用的时间， 可以减少脑损伤本研究将确定是否确定治疗的最佳持续时间（剂量） 低温可以改善结果，如果持续时间反应曲线的发展可以证实在一个 OHCA幸存者的更广泛的儿科人群。我们假设，更长的冷却时间将改善 与较短的冷却持续时间相比， 通过Vineland适应性行为量表第三版（Vineland-3）评分进行评估。其主要目标是 该项目旨在确定临床策略，以增加神经系统改善的患者数量。 从OHCA回收这项试验的结果将对儿童具有极其重要的意义， 影响临床实践和监管评估。冷却时间对疗效的儿科影响 在心脏骤停患者（P-ICECAP）试验中，模仿正在进行的成人ICECAP试验，使用创新的 自适应剂量发现方法，允许探索广泛的潜在持续时间， 将主题分配到信息量最大的地方。这项研究将利用 NHLBI/NINDS创新急救护理临床试验网络（SIREN）的战略，该网络经验丰富， 在儿童和成人试验中，目前正在进行当前的成人ICECAP试验。SIREN利用 现有资源，以实现规模经济，并进行重要的临床研究， 从院前、急诊室和ICU住院以及出院。