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

山间医疗保健临床中心 (CC) NHLBI 预防和早期治疗

• 批准号: 9059171
• 负责人: Joseph R Bledsoe
• 金额: $ 31.52万
• 依托单位: IHC HEALTH SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-17 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9059171
• 关键词: Accident and Emergency department; Acute Lung Injury; Adult Respiratory Distress Syndrome; Aspirin; Blood Glucose; Blood Platelets; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Computers; Critical Care; Development; Dipyridamole; Electronics; Enrollment; Evaluation; Functional disorder; Future; Goals; Health; Healthcare; Heart-Lung Machine; Hospitals; IV Fluid; Insulin; Intravenous; Investigation; Lead; Leadership; Life; Manuscripts; Mechanical ventilation; Medical; Medical center; Methods; Mission; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Online Systems; Operative Surgical Procedures; Outcome; Outcome Assessment; Patient Care; Patients; Preparation; Prevention; Prevention therapy; Prevention trial; Protocols documentation; Quality of life; Recording of previous events; Reporting; Research Methodology; Resources; Role; Site; Survivors; Testing; Therapy trial; United States National Institutes of Health; Universities; Utah; Work; base; blood glucose regulation; clinical care; clinical practice; clinical research site; functional outcomes; hemodynamics; improved; innovation; meetings; mortality; neuropsychiatry; operation; prevent; support tools

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.

描述（由申请人提供）：我们的长期目标是通过预防或更好地治疗急性肺损伤或急性呼吸窘迫综合征（ALI/ARDS）来改善对患者的护理。我们将参与PETAL网络临床试验的开发和执行。我们将通过独特的知识专长和资源，包括长期参与ALI/ARDS临床试验的历史，加强PETAL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协议（eProtocols，详细的计算机协议临床医生决策支持工具）的基于Web的版本的应用，使临床研究，评估ALI/ARDS幸存者的长期结局，以及ALI/ARDS病理生理学中血小板的研究中的可复制方法。我们将根据最佳临床实践应用基于Web的电子协议，用于机械通气、血液动力学和静脉（IV）液体支持以及IV胰岛素血糖管理。较新的基于网络的eProtocol版本将比之前的ARDS网络临床试验中使用的eProtocol的早期独立床边版本更容易传播到多个PETAL网络临床中心。我们还希望开发新的电子协议，以满足未来PETAL网络临床试验的需求，从而提高PETAL网络临床研究的科学严谨性和结果可靠性。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可以预防ALI/ARDS。自从我们参与之前的ECLS临床试验以来，体外生命支持（ECLS，心肺机支持）的进展需要重新评估ECLS治疗ALI/ARDS的效果--这是我们第二项拟议临床试验的目标。我们将在两项拟议的临床试验中评估长期结局，并支持所有PETAL Network研究的长期结局评估。我们将具体：每年在PETAL网络临床试验中招募40多名受试者;参与PETAL网络活动并贡献智力;提出两项 证明我们科学能力的临床试验（预防和治疗血小板减少的抗血小板治疗） 用于治疗ARDS的体外生命支持）;提出PETAL网络临床试验子研究，以帮助阐明ALI/ARDS病理生理学并评估长期临床结局;提供计算机协议，以实现可重复的临床研究方法计划和进行长期生活质量、神经精神和功能结局评估;参与PETAL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。