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)

基本信息

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
项目类别：
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

项目摘要

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.

项目概要儿童院外心脏骤停 (OHCA) 是一种悲剧事件，通常会导致死亡或永久性死亡在美国，每年有 7000 多名儿童遭受 OHCA 的脑损伤，但情况有所改善。与成人一样，儿科 OHCA 的结果在很大程度上受到我们保护大脑免受全球影响的能力的限制。成功复苏的脑缺血损伤患者的目标温度管理（TTM）。是目前推荐用于 OHCA 儿童的指南，并优先说明治疗低温（TTM 32-34°C）高于正常体温（TTM 36-37.5°C），以防止发烧，发烧可能会加剧儿童低温治疗的最佳持续时间和患者选择标准仍然存在。未知和冷却设备未经过 FDA 专门批准用于此适应症。机制研究强烈表明，低温持续时间比成人通常使用的持续时间更长这项研究将确定是否确定最佳治疗持续时间（剂量）。低温可以改善结果，并且如果持续时间反应曲线的发展可以确认疗效我们勇敢地说，更长的冷却时间将会改善更多的 OHCA 幸存者。与较短的冷却时间相比，幸存者的生存率更高，神经系统恢复更好，因为通过 Vineland 适应行为量表第三版 (Vineland-3) 评分进行评估本次评估的主要目标。该项目旨在确定临床策略，以增加神经功能改善的患者数量该试验的结果对于儿童来说非常重要，并且会立即恢复。影响临床实践和监管评估。冷却时间对疗效的儿科影响。心脏骤停患者 (P-ICECAP) 试验以正在进行的成人 ICECAP 试验为蓝本，采用创新技术自适应剂量寻找方法，可以有效地探索广泛的潜在持续时间将研究对象分配到信息最丰富的地方。研究将利用研究中心的资源进行。 NHLBI/NINDS 创新紧急护理临床试验网络 (SIREN) 的策略，该网络经验丰富儿童和成人试验，目前正在进行成人 ICECAP 试验。现有资源以实现规模经济并开展跨领域的重要临床研究从入院前、急诊室和 ICU 住院直至出院后。