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: 10705686
• 负责人: Sharon Dziuba Yeatts
• 金额: $ 68.9万
• 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/10705686
• 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; Dose; 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; Periodicals; Population; Procedures; Protocols documentation; Public Health; Publications; Qualifying; Quality of life; Randomized; Recommendation; 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; 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; neuroprotection; 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）是一个悲惨事件，通常导致死亡或永久性 幸存者的脑损伤。美国每年有7000多名儿童在美国遭受OHCA的痛苦和改善 就像成年人一样，儿科OHCA的结果受到保护大脑免受全球侵害的能力的限制 成功复苏的人中的脑缺血性损伤。目标温度管理（TTM） 目前是在OHCA关注的儿童中登记的指南，并符合治疗的优先 低温（TTM 32-34°C）超过了，以防止发烧，以防止发烧，这可能会放大 脑损伤。儿童治疗性体温过低的最佳持续时间和患者选择标准仍然存在 未知和冷却设备未专门批准用于此指示。临床前数据和 机械研究强烈表明，低温持续时间比成人通常使用的时间更长 可以最大程度地减少脑损伤。这项研究将确定是否确定治疗的最佳持续时间（剂量） 体温过低可以改善预后，如果持续时间响应曲线的发展可以确认效率 OHCA存活的小儿种群。我们假设更长的冷却持续时间将改善 与较短的冷却持续时间相比，生存和更好的神经系统恢复，因为 由Vineland自适应行为量表（Vineland-3）评分评估。这个主要目标 项目是确定将增加神经学改善患者数量的临床策略 从OHCA恢复。这项试验的结果在儿童中将非常重要，并且会立即 影响临床实践和监管评估。冷却持续时间对疗效的小儿影响 在正在进行的成人ICECAP试验之后建模的心脏骤停患者（P-ICECAP）试验中使用创新 自适应剂量查找方法，可以探索广泛的潜在持续时间并有效 分配主题最有用的主题。该研究将使用 NHLBI/NINDS策略创新急诊临床试验网络（Siren），这是经验丰富的 在小儿和成人试验中，目前正在进行当前的成人ICECAP试验。警笛杠杆 现有资源以实现规模经济并进行重要的临床调查 从院前，到急诊科和ICU住院以及医院后出院。