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

描述（申请人提供）：NHLBI申办的预防和早期治疗急性肺损伤（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）合作开发和开展随机对照临床试验，以预防或治疗和/或改善患有或有风险的患者的结局，急性肺损伤（ALI）或急性呼吸窘迫 综合征（ARDS）。该网络进行的研究预计将强调预防、早期治疗和多学科办法。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将有两名主要研究者，一名代表肺部和/或重症监护医学，另一名代表抢先体验有肺损伤风险的患者的专业，如急诊医学。每个社区中心必须包括一家初级医院和至少一家其他医院。预计每个CC每年至少入组40例受试者，持续5.5年。“俄亥俄州联盟临床中心”将由俄亥俄州的四家主要医疗机构组成：克利夫兰诊所、位于哥伦布的俄亥俄州州立大学、辛辛那提大学和位于阿克伦的Summa卫生系统。这些机构都收治大量重症患者， 俄亥俄州联合临床中心（Consortium Clinical Center）的研究者和研究协调员在治疗ALI患者和有发展为ALI风险的患者方面经验丰富。俄亥俄州联盟临床中心的人员包括两名曾担任NHLBI申办的ARDS临床试验网络临床中心PI的医生和另外两名曾担任NHLBI申办的多中心“ProCESS”试验（早期脓毒性休克的方案化护理）研究中心PI的医生。俄亥俄州联盟临床中心提出了两项临床试验：1）角质细胞生长因子（KGF）用于预防或治疗感染性肺炎引起的早期ALI和2）锌补充剂用于预防急性肺损伤（ZAP试验）。

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).