CORE--CLINICAL

临床核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的患者样本。资源将 支持中心内的各个协议，促进交互 在调查人员之间，并提供一个连贯的框架 临床研究项目的制定、执行和数据分析。 临床方案被设计为接近最好的可用方案 脓毒症所致急性感染的诊断、评估和治疗策略 肺损伤(ALI)和成人呼吸窘迫综合征(ARDS)。这个 具体目标是： 1.管理涉及脓毒症患者的临床研究 急性肺损伤和急性呼吸窘迫综合征。 。确定符合条件的患者 。获取知情同意并招募患者 。收集临床数据，以提供完整的 患者的临床病程。 。在加入APACHE研究时对疾病的严重程度进行分层 III与逻辑器官功能障碍核心(LODS) 。使用APACHE III和LODS进一步分层每天的疾病严重程度。 。提供一份协议，以确保患者护理标准化。 2.为个别调查人员采购组织和细胞。 。慢性阻塞性肺疾病患者行Ballard导管支气管肺泡灌洗 急性肺损伤与急性呼吸窘迫综合征及无肺通气者 受伤。 。对BAL液进行处理，以便每个项目都将提供细胞- 这些患者体内的游离液体和/或细胞。 3.提供数据管理和临床严重程度索引服务 个人调查员。 。组织和管理临床数据库 。关于研究设计、样本量计算和选择的建议 适当的结果变量 。在登记时充分描述每个患者的病情严重程度 并在整个临床过程中允许根据严重程度进行解释 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