Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung

NHLBI 急性肺疾病预防和早期治疗临床中心 (CC)

• 批准号: 8707064
• 负责人: Robert C Hyzy
• 金额: $ 14.59万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-17 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8707064
• 关键词: Accident and Emergency department; Acute; Acute Lung Injury; Adult Respiratory Distress Syndrome; Azithromycin; Biological; Caring; Cations; Clinic; Clinical; Clinical Research; Clinical Trials; Computerized Medical Record; Continuity of Patient Care; Critical Care; Critical Illness; Development; Early Intervention; Early identification; Early treatment; Eating; Environment; Event; Evolution; Goals; Granulocyte-Macrophage Colony-Stimulating Factor; Health system; Inflammatory; Inflammatory Response; Institution; Intensive Care Units; Intervention; Length of Stay; Lung; Medical; Medicine; Michigan; Mining; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Operative Surgical Procedures; Organ failure; Outcome; Outcome Measure; Participant; Patients; Populations at Risk; Prevention; Principal Investigator; Protocols documentation; Recovery; Recovery of Function; Recruitment Activity; Research Personnel; Resolution; Risk; Sepsis; Severities; Site; Study Subject; Translational Research; United States; Universities; Ventilator; attributable mortality; disability; early onset; experience; frontier; functional outcomes; improved; injury prevention; lung injury; microbiome; monocyte; mortality; novel; pre-clinical research; prevent; primary outcome; public health relevance; response; screening; success

DESCRIPTION (provided by applicant): The goal of this project is to employ novel therapies in patients who are at risk for or who have early ARDS in order to reduce the significant attributable mortality and to improve both short term and long term morbidities (1,2). As a participant in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, our specific aims are: 1. The creation of a two site multi-disciplinary network for recruitment into PETAL studies. Principal Investigators and Co-investigators from the Divisions of Pulmonary and Critical Care Medicine, Acute Care Surgery, and the Emergency Department Intensive Care Unit (ED-ICU) at the University of Michigan will collaborate to insure early identification and robust recruitment o study subjects. Additionally, investigators from the Emergency Department and the Division of Pulmonary and Critical Care Medicine of Henry Ford Health System, our second site in this network, have joined to create a rich environment in which to recruit patients for PETAL studies. This environment is strengthened by the inclusion of a fully integrated ED-ICU, providing a unique continuum of care for critically ill patients at these institutions, permitting early recruitment and intervention in these patients. 2. The annual recruitment of at least 40 high quality enrollees into PETAL protocols through the continuation and initiation of multiple overlapping recruitment strategies, including a novel alert mechanism through the electronic medical record, calculation of lung injury prevention scores, targeted capture of select at risk populations and traditional coordinator screening. 3. Prevention of ARDS: To determine the effect of GM-CSF administration on relevant clinical outcomes in patients with severe sepsis who are at risk for ARDS. The primary outcome measures are 28- and 90-day mortality. Major secondary end-points include the development/progression of ARDS and other organ failures, resolution of sepsis, duration of ICU and hospital stay, and long term functional recovery. Biological outcomes include monocyte innate responses and systemic inflammatory responses. 4. Early intervention in ARDS: To determine the effect of azithromycin administration on relevant clinical outcomes in patients with early onset ARDS. The primary outcome measures are 28- and 90-day mortality. Major secondary end-points include ventilator-free days, organ failure free days, infectious complications, duration of ICU and hospital stay, and long term functional recovery. An important biological outcome to be assessed is the influence of azithromycin therapy on temporal changes in the lung microbiome. These highly novel studies are to be led by a Co-Investigator with outstanding expertise in this arena.

描述（由申请方提供）：本项目的目标是在有早期ARDS风险或患有早期ARDS的患者中采用新疗法，以降低显著的归因死亡率并改善短期和长期发病率（1，2）。作为预防和早期治疗急性肺损伤（PETAL）网络的参与者，我们的具体目标是： 1.创建两个研究中心的多学科网络，用于PETAL研究的招募。来自密歇根大学肺部和重症监护医学、急性护理外科和急诊科重症监护室（ED-ICU）的主要研究者和合作研究者将合作，以确保研究受试者的早期识别和稳健招募。 此外，来自急诊科和亨利福特卫生系统（我们在该网络中的第二个站点）的肺部和重症监护医学部的研究人员也加入进来，为PETAL研究招募患者创造了丰富的环境。这种环境通过纳入完全集成的ED-ICU得到加强，为这些机构的重症患者提供独特的连续护理，允许早期招募和干预这些患者。 2.通过继续和启动多个重叠招募策略，包括通过电子病历的新型警报机制、肺损伤预防评分的计算、选择风险人群的目标捕获和传统协调员筛选，每年招募至少40名高质量入组者进入PETAL方案。 3.预防ARDS：确定GM-CSF给药对有ARDS风险的严重脓毒症患者相关临床结局的影响。主要结局指标为28天和90天死亡率。主要次要终点包括ARDS和其他器官衰竭的发展/进展、脓毒症的消退、ICU和住院时间以及长期功能恢复。生物学结果包括单核细胞先天反应和全身炎症反应。 4.急性呼吸窘迫综合征的早期干预：确定阿奇霉素给药对早发急性呼吸窘迫综合征患者相关临床结局的影响。主要结局指标为28天和90天死亡率。主要次要终点包括无呼吸机天数、无器官衰竭天数、感染并发症、ICU和住院时间以及长期功能恢复。需要评估的一个重要生物学结局是阿奇霉素治疗对肺部微生物组时间变化的影响。这些高度新颖的研究将由在该竞技场领域具有杰出专业知识的合作研究者领导。