CORE--CLINICAL

临床中心的使命是提供人员，设施， 以及生成临床数据库所需的组织结构 以及项目1、2、3和4的患者标本。这些资源将 支持中心内的个别协议，促进互动 研究人员之间，并提供一个有凝聚力的框架， 临床研究项目的制定、执行和数据分析。 临床方案旨在接近现有的最佳方案 急性脓毒症的诊断评估和治疗策略 肺损伤（ALI）和成人呼吸窘迫综合征（ARDS）。的 具体目标是： 1.管理涉及脓毒症诱导患者的临床研究 急性肺损伤和ARDS。 .确定合格患者 .获得知情同意并招募患者 .收集临床数据，以提供 患者的临床病程。 .入组研究时使用APACHE对疾病严重程度进行分层 逻辑器官功能障碍核心（LODS） .每天使用APACHE III和LODS进一步对疾病严重程度进行分层。 .提供一个协议，以确保病人护理标准化。 2.为个别研究者获取组织和细胞。 .在以下患者中进行Ballard导管支气管肺泡灌洗（BAL） 急性肺损伤和ARDS以及无肺通气的志愿者 损伤 .处理BAL液，以便为每个项目提供细胞- 从这些患者的游离液体和/或细胞中。 3.提供数据管理和临床严重程度索引服务， 个别调查员。 .组织和管理临床数据库 .关于研究设计、样本量计算和 适当的结果变量 .在入组时充分描述每例患者的疾病严重程度 在整个临床过程中， 分子生物学数据 .协助统计应用和数据分析

The mission of the Clinical Core is to provide the personnel, facilities, and organizational structure necessary to generate the clinical database and patient specimens for projects 1, 2, 3 and 4. The resources will support individual protocols within the Center, facilitate interactions between investigators, and provide a cohesive framework to the formulation, execution, and data analysis of clinical research projects. The clinical protocol is designed to approximate the best available strategies for diagnostic assessment nd therapy of sepsis induced acute lung injury (ALI) and adult respiratory distress syndrome (ARDS). The specific aims are: 1. To manage the clinical studies involving patients with sepsis-induced acute lung injury and ARDS. . Identify eligible patients . Obtain informed consent and enroll patients . Collect clinical data to provide complete characterization of the patients' clinical course. . Stratify severity of illness upon enrollment into the study with APACHE III and the Logistic Organ Dysfunction core (LODS) . Further stratify severity of illness daily with APACHE III and the LODS. . Provide a protocol to insure that patient care is standardized. 2. To procure tissue and cells for individual investigators. . Perform Ballard catheter bronchoalveolar lavage (BAL) in patients with acute lung injury and ARDS and in ventilated volunteers without lung injury. . Process the BAL fluid such that each project will be supplied with cell- free fluid an/or cell cells from these patients. 3. To provide data management and clinical severity indexing services to individual investigators. . Organize and manage the clinical database . Advice on study design, sample size calculations and selection of appropriate outcome variables . Fully characterize each patient's severity of illness upon enrollment and throughout clinical course to allow severity-specific interpretation of molecular biologic data . Assist with statistical applications and data analysis