Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED)

静脉注射镁：在急诊科治疗的儿童哮喘中立即使用 (IMPACT-ED)

• 批准号: 10371619
• 负责人: Michael David Johnson
• 金额: $ 38.22万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10371619
• 关键词: Accident and Emergency department; Acute; Address; Adrenal Cortex Hormones; Adverse event; Albuterol; Applied Research; Asthma; Blood Pressure; Blood Pressure Monitors; Blood specimen; Breathing; Bronchodilator Agents; Child; Childhood; Childhood Asthma; Chronic Disease; Clinical; Clinical Trials; Complex; Consent; Cost Savings; Critically ill children; Data; Development; Devices; Direct Costs; Dose; Drug Kinetics; Emergency Care; Enrollment; Evaluation; Facilities and Administrative Costs; Funding; Future; Goals; Guidelines; Health Care Costs; Home; Hospital Costs; Hospitalization; Hypotension; Infusion procedures; Inhalation; Intervention; Intravenous; Intravenous Bolus; Ions; Knowledge; Length; Life; Magnesium; Magnesium Sulfate; Measures; Medicine; Modeling; Monitor; Multicenter Trials; National Heart, Lung, and Blood Institute; Needles; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Pilot Projects; Placebos; Positioning Attribute; Procedures; Protocols documentation; Publishing; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Respiratory distress; Safety; Saline; Savings; Schools; Serum; Serum Magnesium Level; Sickle Cell Anemia; Site; Standardization; Steroids; Study Subject; Testing; Time; Translating; Work; arm; base; clinical database; design; double-blind placebo controlled trial; experience; improved; novel; patient safety; pediatric emergency; pharmacodynamic model; pharmacokinetic model; pilot trial; placebo controlled trial; prevent; prospective; randomized placebo-controlled clinical trial; randomized trial; standard care

PROJECT SUMMARY ABSTRACT Asthma is the most common chronic illness of childhood and a leading cause of hospitalization and healthcare costs for children. Most children hospitalized for asthma first receive breathing treatments and steroid medicines in an emergency department (ED) according to national guidelines. An additional medicine, intravenous magnesium sulfate (IVMg), may help severely sick children avoid hospitalization. National asthma guidelines recommend IVMg for severely sick children, but note a lack of consistent evidence to support this recommendation. Only about one in four children hospitalized for asthma received IVMg in the ED. Estimates of the potential effects of broader use of IVMg on hospitalization are limited by the small size of prior trials, but increased use could potentially avoid 18,000 hospitalizations each year, producing direct cost savings of $65 million yearly in addition to saving significant indirect costs of missed school and parental work. A few major questions remain about IVMg. First, it has not been tested early in ED treatment, when the impact on hospitalization would be greatest. Second, the clinical impact of hypotension, a driver of low utilization, is not characterized in prior trials or clinical databases. Third, no trials have compared different IVMg doses or measured serum magnesium levels to optimize dosing, so the most effective dose is unknown. All prior trials of IVMg in children with asthma have been small. A large randomized, placebo-controlled clinical trial of IVMg that could answer whether IVMg can reduce hospitalization might be challenging for a few reasons. First, enrolling patients fast enough to give IVMg early in ED treatment is challenging. Second, understanding blood pressure changes after IVMg is essential to plan safety monitoring for a larger trial. Third, little pharmacologic information has been gathered to guide the doses of IVMg to be tested. We must conduct a small pilot clinical trial to test our procedures and gather necessary information to plan the large trial. The Pediatric Emergency Care Applied Research Network (PECARN) is a network of children’s EDs that has conducted similar research involving acutely ill children. Our goals in this project are to: 1. Demonstrate the feasibility of enrolling children in the ED with severe acute asthma in a multicenter, randomized, controlled trial of placebo, low-dose IVMg, or high-dose IVMg. 2. Demonstrate the feasibility of timely delivery of study medication to enrolled patients and assessment of blood pressure and associated adverse events in a standardized protocol. 3. Externally validate a previously constructed PK model and develop a combined PK/PD model for IVMg using magnesium (total and ionized) serum concentrations and their correlation with measures of safety and respiratory distress in children with asthma. After completing this pilot trial in three sites, we will plan a multi-center randomized trial of IVMg in children with severe acute asthma at more sites to enroll enough children to know if IVMg can reduce hospitalization.

项目摘要摘要 哮喘是最常见的童年慢性疾病，也是住院和医疗保健的主要原因 儿童的费用。 急诊科（ED）的药物根据国家指南。 静脉注射硫酸镁（IVMG），可能有助于生病的儿童避免猪油化。 指南建议IVMG对生病的孩子，但请注意，缺乏一致的证据来支持这一点 建议在ED中接受IVMG的儿童 更广泛使用IVMG对Hosspital化的潜在影响受到先前试验的少量限制 使用增加可能会避免每年18,000次住院，从而节省65美元的直接成本 除了节省学业和父母工作的大量间接成本外，每年一百万。 关于IVMG的一些主要问题。 关于住院最大，第二，低利用率的临床影响是 未在先前的试验或临床数据库中进行表征，没有试验的IVMG剂量或 测量的血清镁水平以优化给药，因此最有效的剂量未知。 所有先前在哮喘儿童中的IVMG试验都很小。 IVMG的试验可以回答IVMG是否可以减少少数挑战的住院 原因。 了解血液IVMG IVMG之后的变化对于计划安全性监测至关重要。 几乎没有收集药理学信息来指导要测试的IVMG剂量。 一项小型试点试验，以测试我们的程序并收集必要的信息来计划大型试验。 小儿紧急护理护理应用研究网络（PECARN）是一个儿童ED网络， 抑制类似的研究涉及急性病的孩子。 1。证明将儿童纳入急诊室的可行性 安慰剂，低剂量IVMG或高剂量IVMG的多中心，随机，对照试验。 2。证明及时将研究药物提供给入学的患者的盛宴， 评估标准化方案中血压和相关不良事件的评估。 3。外部验证 IVMG使用镁（总和离子化）血清收缩及其与其与之相关 哮喘儿童的安全性和呼吸窘迫的措施。 在三个站点完成此试验试验后，我们将计划对患有患有的儿童进行IVMG的多中心随机试验。 在更多部位，严重的急性哮喘注册足够的儿童以了解IFMG可以减少住院治疗。