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.
Acute Lung Injury or Acute Respiratory Distress Syndrome (ALI/ARDS) continues to cause major morbidity and mortality, with considerable long-term morbidity. Our goal of improving the care of patients with ALI/ARDS by preventing or better treating ALI/ARDS is relevant to the NIH mission of improving the health of patients.
|Huang, David T; Angus, Derek C; Moss, Marc et al. (2017) Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc 14:124-133|
|Sjoding, Michael W; Schoenfeld, David A; Brown, Samuel M et al. (2017) Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome. Ann Am Thorac Soc 14:110-117|
|Sjoding, Michael W; Brown, Samuel M; Moss, Marc et al. (2017) Reply: Validity of the Posttraumatic Stress Symptoms-14 Instrument in Acute Respiratory Failure Survivors. Ann Am Thorac Soc 14:1048-1049|
|Brown, Samuel M; Duggal, Abhijit; Hou, Peter C et al. (2017) Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Mechanically Ventilated Patients in the ICU: A Prospective, Observational Study. Crit Care Med 45:1317-1324|
|Benthin, Cody; Pannu, Sonal; Khan, Akram et al. (2016) The Nature and Variability of Automated Practice Alerts Derived from Electronic Health Records in a U.S. Nationwide Critical Care Research Network. Ann Am Thorac Soc 13:1784-1788|
|Brown, Samuel M; Grissom, Colin K; Moss, Marc et al. (2016) Nonlinear Imputation of Pao2/Fio2 From Spo2/Fio2 Among Patients With Acute Respiratory Distress Syndrome. Chest 150:307-13|
|Grissom, Colin K; Hirshberg, Eliotte L; Dickerson, Justin B et al. (2015) Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*. Crit Care Med 43:288-95|