CORE--CLINICAL

核心--临床

• 批准号: 6202608
• 负责人: PAUL N LANKEN
• 金额: $ 15.58万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-01 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6202608
• 关键词: adult respiratory distress syndrome; biomedical facility; data management; disease /disorder proneness /risk; human subject; patient /disease registry

Core A (Clinical Core) has three goals: 1. to enroll and characterize all patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS); 2. to provide access to patients and clinical samples from selected patients with ALI/ARDS or from those at risk for ALI/ARDS for the SCOR research projects; and 3. to facilitate coordination within this SCOR and among ALI SCOR. This Core has the following four specific aims: 1. Registry of Patients with Major Trauma At Risk for ALI/ARDS (Trauma Cohort): To develop a prospective registry of patients with major trauma admitted to Surgical Intensive Care Unit (ICU) at the Hospital of the University of Pennsylvania (HUP) and the Medical-Surgical ICU Brandywine Hospital (BWH) who are at risk for developing ALI/ARDS in the first 5 days after trauma. This registry will form the basis of the prospective cohort and nested case-control studies of patients with major trauma in Projects 1 and 3. 2. Registry of Patients with Sepsis At Risk for ALI/ARDS (Sepsis Cohort): To develop a prospective registry of patients with sepsis admitted to the ICUs who are at risk for developing ALI/ARDS in the first 5 days after onset of sepsis. This registry will form the basis of the prospective cohort and nested case-control studies of patients with sepsis in Projects 1 and 3. 3. Registry of All Patients with ALI and ARDS: To develop and maintain a prospective ALI/ARDS Registry by identifying intensive care unit (ICU) patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Subsets of this registry, i.e., patients with ARDS associated with major trauma or sepsis, will be used for the prospective cohort studies of ARDS in Projects 1 and 3 and will be enrolled as subjects in the randomized clinical trial of dl-alpha tocopherol as an anti-oxidant in Project 3. 4. Organized Clinical Data and Sample Collection System for Patient Populations under Study: To provide an organized system to collect and enter clinical data into the SCOR Central Data Base and to collect and distribute samples of blood and urine for the prospective cohort and nestled case-control studies involving patients who are at risk for ALI/ARDS (Specific Aims 2 and 3, above) in Projects 1 and 3 as well as the studies of patients with ARDS (Specific Aim 3, above).

核心A（临床核心）有三个目标：1。招募并描述所有 急性肺损伤（ALI）或急性呼吸窘迫患者 综合征（ARDS）; 2.提供接触患者和临床样本的机会， 来自选定的ALI/ARDS患者或有ALI/ARDS风险的患者 用于SCOR研究项目;以及3.促进内部协调， 这一次，在阿里和阿里之间。本核心有以下四个具体的 目的： 1.有ALI/ARDS风险的严重创伤患者登记研究（创伤 队列）：建立严重创伤患者的前瞻性登记研究 1999年12月28日， 宾夕法尼亚大学（HUP）和医疗外科ICU Brandywine 在前5天内有发生ALI/ARDS风险的住院患者（BWH） 在创伤后。该登记研究将构成前瞻性队列研究的基础 对项目中严重创伤患者的巢式病例对照研究 1和3. 2.有ALI/ARDS风险的脓毒症患者登记研究（脓毒症队列）： 建立一个前瞻性的脓毒症患者登记， ICU患者在术后前5天内有发生ALI/ARDS的风险 败血症发作该登记册将构成未来 项目中脓毒症患者的队列和巢式病例对照研究 1和3. 3.所有ALI和ARDS患者的登记研究：建立和维持一个 通过确定重症监护病房（ICU）的前瞻性ALI/ARDS登记研究 急性肺损伤（ALI）或急性呼吸窘迫患者 综合征（ARDS）。本登记册的子集，即，ARDS患者 与严重创伤或脓毒症相关，将用于前瞻性研究。 项目1和3中的ARDS队列研究，并将招募为 在DL-α生育酚作为抗生育药物的随机临床试验中， 项目3中的抗氧化剂。 4.组织化的患者临床数据和样本采集系统 研究人群：提供一个有组织的系统， 将临床数据输入SCOR中央数据库， 分发前瞻性队列的血液和尿液样本， 巢式病例对照研究，涉及有风险的患者， 项目1和3中的急性肺损伤/急性呼吸窘迫综合征（上文具体目标2和3）以及 ARDS患者的研究（具体目标3，上文）。