Ohio Consortium Clinical Center for the NHLBI Prevention and Early Treatment of A

俄亥俄州 NHLBI 预防和早期治疗联盟临床中心

• 批准号: 8707155
• 负责人: Robert Duncan Hite
• 金额: $ 16.07万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 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/8707155
• 关键词: Acute; Acute Lung Injury; Address; Adult Respiratory Distress Syndrome; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collection; Communication; Conduct Clinical Trials; Critical Care; Critical Illness; Data; Development; Discipline; Early treatment; Elements; Emergency Medicine; Enrollment; Epithelium; FDA approved; Grant; Health system; Hospitals; Human Resources; Infection; Institution; Instruction; Intervention; Leadership; Lung; Maintenance; Manufacturer Name; Medical; Medical center; Medicine; Monitor; National Heart, Lung, and Blood Institute; Ohio; Outcome; Patients; Performance; Pharmacologic Substance; Physicians; Pneumonia; Population; Prevention; Principal Investigator; Protocols documentation; Provider; Randomized Controlled Clinical Trials; Recovery; Research; Research Design; Research Personnel; Resources; Resuscitation; Risk; Risk Factors; Role; Scientist; Sepsis; Septic Shock; Site; Supplementation; Time; Trauma; United States National Institutes of Health; Universities; Vision; Zinc; Zinc deficiency; base; clinically significant; cytokine; experience; fibroblast growth factor 10; improved; injury prevention; interdisciplinary approach; keratinocyte growth factor; lung injury; lung repair; medical specialties; member; novel; novel strategies; organizational structure; patient population; prevent; public health relevance; response; success

DESCRIPTION (provided by applicant): The purpose of the NHLBI sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network is to constitute a network of Clinical Centers (CC) to collaborate with the Clinical Coordinating Center (CCC) to develop and conduct randomized controlled clinical trials to prevent or treat, and/or improve the outcome of patients with, or who are at risk for, Acute Lung Injury (ALI) or the Acute Respiratory Distress Syndrome (ARDS). Studies conducted by this Network are expected to emphasize prevention, early treatment and multidisciplinary approaches. The Network will consist of approximately eleven Clinical Centers (CCs) and a Clinical Coordinating Center (CCC). Each CC will have two principal investigators, one representing pulmonary and/or critical care medicine and the other representing a specialty with early access to patients at risk for lung injury, such as emergency medicine. Each CC must consist of a primary hospital and at least one other hospital. Each CC will be expected to enroll a minimum of 40 subjects per year for 5.5 years. The "Ohio Consortium Clinical Center" will consist of four major medical institutions in the state of Ohio: Cleveland Clinic, The Ohio State University in Columbus, University of Cincinnati and Summa Health System in Akron. These institutions all treat a large number of critically ill patients, and the investigators and research coordinators of the Ohio Consortium Clinical Center are experienced in the treatment of patients with ALI, and patients at-risk to develop ALI. The personnel of the Ohio Consortium Clinical Center includes two physicians who have served as Clinical Center PIs for the NHLBI sponsored ARDS Clinical Trial Network and two other physicians who have served as site PIs in the NHLBI sponsored multi-center "ProCESS" trial - (Protocolized Care for Early Septic Shock). The Ohio Consortium Clinical Center proposes two clinical trials: 1)Keratinocyte Growth Factor (KGF) for The Prevention or Treatment of Early ALI Due to Infectious Pneumonia and 2) Zinc supplementation for Acute Lung Injury Prevention (ZAP Trial).

描述（由申请人提供）：NHLBI 资助的急性肺损伤预防和早期治疗 (PETAL) 临床试验网络的目的是建立一个临床中心 (CC) 网络，与临床协调中心 (CCC) 合作开发进行随机对照临床试验，以预防或治疗急性肺损伤 (ALI) 或急性呼吸窘迫患者，和/或改善其预后 综合症（ARDS）。该网络进行的研究预计将强调预防、早期治疗和多学科方法。该网络将由大约 11 个临床中心 (CC) 和一个临床协调中心 (CCC) 组成。每个CC将有两名主要研究人员，一名代表肺部和/或重症监护医学，另一名代表早期接触有肺损伤风险的患者的专业，例如急诊医学。每个CC 必须由一家主要医院和至少一家其他医院组成。每个 CC 预计每年至少招收 40 名科目，持续 5.5 年。 “俄亥俄联盟临床中心”将由俄亥俄州四家主要医疗机构组成：克利夫兰诊所、哥伦布俄亥俄州立大学、辛辛那提大学和阿克伦苏玛健康系统。这些机构都收治着大量的重症患者，并且 俄亥俄联盟临床中心的研究人员和研究协调员在治疗 ALI 患者以及有发生 ALI 风险的患者方面拥有丰富的经验。俄亥俄联盟临床中心的人员包括两名曾担任 NHLBI 赞助的 ARDS 临床试验网络的临床中心 PI 的医生，以及另外两名曾在 NHLBI 赞助的多中心“ProCESS”试验中担任现场 PI 的医生 - （协议化）早期感染性休克的护理）。俄亥俄联盟临床中心提出两项临床试验：1) 角质细胞生长因子 (KGF) 用于预防或治疗传染性肺炎引起的早期 ALI；2) 补充锌用于预防急性肺损伤（ZAP 试验）。