Intermountain Healthcare Clinical Center (CC) for the NHLBI Prevention and Early

描述(申请人提供)：我们的长期目标是通过预防或更好地治疗ALI/ARDS来改善对急性肺损伤或急性呼吸窘迫综合征(ALI/ARDS)患者的护理。我们将参与Petal网络临床试验的开发和执行。我们将通过独特的智力专长和资源，包括长期参与ALI/ARDS临床试验的资源，加强PEATAL网络的运作 自1974年以来，我们的可复制的电子临床研究和护理方案的网络版本(电子协议，详细的计算机方案临床医生决策支持工具)的应用使得临床研究、ALI/ARDS幸存者的长期结果评估以及ALI/ARDS病理生理学中的血小板调查具有可重复性的方法。我们将在最佳临床实践的基础上应用基于网络的电子协议，用于机械呼吸、血液动力学和静脉(IV)液体支持，以及使用IV胰岛素进行血糖管理。与之前ARDS网络临床试验中使用的早期床边版本的ePROTOCOLS相比，基于Web的较新版本的ePROTOCOLS将更容易传播到多个PEATAL网络临床中心。我们还希望开发新的eProtocols来满足未来PEAL网络临床试验的需要，从而提高PEAL网络临床研究的科学严谨性和结果可信度。我们建议进行一项临床试验，以测试阿司匹林和潘生丁联合抗血小板治疗是否能预防ALI/ARDS。自从我们参与了之前的ECLS临床试验以来，体外生命支持(ECLS，心肺机支持)方面的进展，需要重新评估使用ECLS治疗ALI/ARDS-这是我们第二次拟议的临床试验的目标。我们将在我们的两个拟议的临床试验中评估长期结果，并将支持在所有PEAL网络研究中评估长期结果。我们将具体：每年招募40多名受试者参加Petal网络临床试验；参与Petal网络活动，贡献智力；提出两项 证明我们的科学能力的临床试验(用于预防和治疗的抗血小板治疗 为ARDS的治疗提供体外生命支持；提出有助于阐明ALI/ARDS病理生理学和评估长期临床结果的PEATAL网络临床试验分研究；提供计算机规程，使可重复使用的临床研究方法成为可能；计划和进行长期生活质量、神经精神和功能结果评估；以及参与PEATAL网络报告、演示文稿和手稿的准备和交付。我们提出的预防ALI/ARDS和加强对已建立的ALI/ARDS的治疗的工作将与NIH改善患者健康的使命相关。

DESCRIPTION (provided by applicant): Our long-term goal is to improve the care of patients with Acute Lung Injury or Acute Respiratory Distress Syndrome (ALI/ARDS) by preventing or better treating ALI/ARDS. We will participate in development and execution of PETAL Network clinical trials. We will enhance the operations of the PETAL Network through unique intellectual expertise and resources that include a long history of participation in clinical trials of ALI/ARDS since 1974, application of Web-based versions of our replicable electronic clinical research and care protocols (eProtocols, detailed computer protocol clinician decision-support tools) that enable reproducible methods in clinical research, evaluation of long-term outcomes in survivors of ALI/ARDS, and investigations of platelets in the pathophysiology of ALI/ARDS. We will apply Web-based eProtocols based on best clinical practices for mechanical ventilation, hemodynamic and intravenous (IV) fluid support, and blood glucose management with IV insulin. The newer Web-based eProtocol versions will be easier to disseminate to multiple PETAL Network Clinical Centers, than earlier stand-alone bedside versions of eProtocols used in previous ARDS Network clinical trials. We also expect to develop new eProtocols to meet the needs of future PETAL Network clinical trials, thus increasing scientific rigor and result credibilty for the PETAL Network clinical studies. We propose a clinical trial to test whether combined antiplatelet therapy with aspirin and dipyridamole prevents ALI/ARDS. Advances in extracorporeal life support (ECLS, heart-lung machine support), since our participation in previous ECLS clinical trials, warrant re-evaluation of ALI/ARDS treatment with ECLS - the objective of our second proposed clinical trial. We will evaluate long-term outcomes in our two proposed clinical trials and we will support assessment of long-term outcomes in all PETAL Network studies. We will specifically: Enroll more than 40 subjects/year in PETAL Network clinical trials; Participate in PETAL Network activities and contribute intellectually; Propose two clinical trials that demonstrate our scientific capacities (Antiplatelet therapy for prevention and Extracorporeal life support for treatment of ARDS); Propose PETAL Network clinical trial sub-studies that help elucidate ALI/ARDS pathophysiology and evaluate long-term clinical outcomes; Provide computer protocols that enable reproducible clinical research methods (eProtocols); Plan and conduct long-term quality of life, neuropsychiatric, and functional outcome assessments; and Participate in preparation and delivery of PETAL Network reports, presentations, and manuscripts. Our proposed work to prevent ALI/ARDS and to enhance treatment of established ALI/ARDS will be relevant to the NIH mission of improving the health of patients.