Treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome

急性肺损伤和急性呼吸窘迫综合征的治疗

• 批准号: 8602447
• 负责人: Roy G. Brower
• 金额: $ 7.6万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2013-07-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602447
• 关键词: Acute; Acute Lung Injury; Adult; Adult Respiratory Distress Syndrome; Caring; Characteristics; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Consent Forms; Critical Illness; Edema; Electronics; Eligibility Determination; Enrollment; Ethics; Gender; Hypoxemia; Intensive Care Units; Lung Inflammation; Natural History; Outcome; Pathology; Patients; Pharmaceutical Preparations; Procedures; Protocols documentation; Publications; Research Personnel; Resources; Respiratory distress; Review Committee; Sampling; Syndrome; Teleconferences; Voting; base; data exchange; improved; meetings; member; mortality; patient population; prevent; protocol development

Acute lung injury (ALI) and its more severe form, adult respiratory distress (ARD), is a devastating clinical syndrome of sudden lung inflammation that results in severe edema and hypoxemia and requires care in the intensive care unit. Mortality is between 30-40% in controlled settings. To date, no single drug has proven effective for improving mortality in ALI/ARDS despite many large and small clinical trials. The objective of the Clinical Research Network (ARDSNet) is to develop and conduct clinical research trials to prevent, treat, and improve the outcome of patients with acute lung injury, acute respiratory distress syndrome, and possibly other related critical illnesses. Enroll a minimum of 30 patients per year with ALI/ARDS. Describe in detail the gender and racial characteristics of the patient population. Set priorities for and participate in protocol development, developing specific protocols, determination of subject eligibility criteria, developing procedures for electronic transmission of data, developing sample consent forms. Be voting members of the SC; attend meetings and teleconferences. Participate in one or more of a number of subcommittees (e.g., publications, ethics, pathology, natural history, and progress assessment) which will hold meetings and teleconferences on an as-needed basis. Investigators may be asked to participate in Protocol Review Committee (PRC) and Data and Safety Monitoring Board (DSMB) meetings and teleconferences to serve as a resource.

急性肺损伤(ALI)及其更严重的形式成人呼吸窘迫(ARD)是一种破坏性的临床综合征，突发性肺部炎症导致严重的浮肿和低氧血症，需要在重症监护室护理。在受控环境中，死亡率在30%-40%之间。到目前为止，尽管进行了许多大大小小的临床试验，但还没有一种药物被证明能有效地提高ALI/ARDS的死亡率。临床研究网络(ARDSNet)的目标是开发和进行临床研究试验，以预防、治疗和改善急性肺损伤、急性呼吸窘迫综合征和其他可能相关危重疾病患者的预后。 每年至少招募30名ALI/ARDS患者。详细描述患者群体的性别和种族特征。 确定制定议定书的优先事项并参与其中，拟定具体议定书，确定受试者资格标准，制定电子数据传输程序，编写样本同意书。 成为常委会有投票权的成员；参加会议和电话会议。 参加一个或多个小组委员会(例如，出版物、伦理、病理学、自然历史和进展评估)，这些委员会将根据需要举行会议和电话会议。调查人员可能被要求参加议定书审查委员会(PRC)和数据与安全监测委员会(DSMB)的会议和电话会议，作为一种资源。