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ALI/ARDS来改善急性肺损伤或急性呼吸窘迫综合征（ALI/ARDS）患者的护理。我们将参加Petal网络临床试验的开发和执行。我们将通过独特的智力专业知识和资源来增强Petal网络的运营，包括参与ALI/ARDS临床试验的悠久历史 自1974年以来，我们可复制的电子临床研究和护理方案的基于网络的版本（Eropotss，详细的计算机协议临床医生决策支持工具）在临床研究中启用可重复的方法，评估ALI/ARDS幸存者的长期成果以及对ALI/ARDS ARDS ARDS ARDS ARDSARYPHASSIGYLYS PLAWELETS的幸存者的长期结果。我们将根据最佳临床实践应用基于Web的Erotocols，用于机械通气，血液动力学和静脉内（IV）液体支持以及使用IV胰岛素进行血糖管理。与以前ARDS网络临床试验中使用的Eprotocols相比，基于Web的新型Eropocol版本将更容易传播到多个花瓣网络临床中心。我们还期望开发新的EProtocols，以满足未来的Petal网络临床试验的需求，从而提高了科学严谨性并为Petal网络临床研究提供了信用。我们提出了一项临床试验，以测试将抗血小板疗法与阿司匹林和二吡啶氨基二氨基疗法结合在一起，可防止ALI/ARDS。由于我们参与了先前的ECLS临床试验，因此体外生命支持的进步（ECLS，心肺机支持），通过ECLS对ALI/ARDS治疗进行保证重新评估，这是我们第二次提出的临床试验的目的。我们将评估我们提出的两项临床试验中的长期结果，并将支持所有花瓣网络研究中对长期结果的评估。我们将具体：在花瓣网络临床试验中注册40多名受试者；参加花瓣网络活动并在智力上做出贡献；提出两个 证明我们的科学能力的临床试验（用于预防和 体外生命支持治疗ARDS）；提出了花瓣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果；提供计算机协议，以实现可重现的临床研究方法（EPOTOLS）；计划和进行长期生活质量，神经精神病学和功能结果评估；并参与花瓣网络报告，演示文稿和手稿的准备和交付。我们提出的旨在防止ALI/ARD的工作并增强已建立的ALI/ARDS的治疗将与NIH的使命相关，以改善患者的健康状况。