Almost 50 years ago, Dr. Tom Petty and his surgical colleagues identified 12 patients at the University of Colorado with similar clinical symptoms: severe hypoxemia, bilateral infiltrates on chest radiograph, and diminished static pulmonary compliance. The clinical features of these patients were published as a case series in the Lancet and serve as the initial description of the acute respiratory distress syndrome (ARDS). This seminal discovery launched a long and productive history of ARDS research in Denver. We have been a member of the ARDS Network since its inception in 1994. Our multi-disciplinary and collaborative critical care research group is experienced in conducting high quality multi-center clinical trials. As a result, we have always been one of the top enrolling ARDS Network sites for over 19 years. The University of Colorado's Department of Emergency Medicine was one of the first residency training programs in Emergency Medicine and remains one of most highly regarded training programs in the country. Their extramural funding has grown rapidly in the past decade especially in the area of critical care research. The Division of Pulmonary Sciences and Critical Care Medicine and the Department of Emergency Medicine have an established record of effective collaborations in both patient-oriented and research initiatives. Building on this ARDS Network research infrastructure, we will create an integrated Critical Care and Emergency Medicine clinical center to effectively conduct clinical trials for the prevention and early treatment of acute lung injury. This Colorado PETAL Clinical Center will exceed meet our enrollment obligations;maintain excellence in the quality of protocol compliance, data acquisition, and regulatory responsibilities;actively participate and contribute to the subsequent responsibilities of the steering and other PETAL committees;and contribute to the improved care of patients with and at risk for ARDS.

Public Health Relevance

Acute Respiratory Distress Syndrome (ARDS) is a serious form of acute ling injury that affects nearly 200,000 individuals in the United States each year. Due to advances in mechanical ventilatory and fluid strategies, the outcomes of ARDS patients have improved significantly over the last decade. The goal of this new NHLBI PETAL initiative is to test therapies that will either prevent the development of ARDS in patients at risk for developing the syndrome, or improve outcomes for patients with early ARDS. The University of Colorado Division of Pulmonary and Critical Care and Department of Emergency Medicine have previously collaborated on clinical initiatives including optimizing the transition of care for critically ill patients from the Emergency Department to the Intensive Care Units. In addition, investigators from each group have a long standing history of performing outstanding ARDS and critical care research, and conducting multi-center clinical trials. The overarching aims of the Colorado Clinical Center for the PETAL network will be: 1) To be an effective clinical center that achieves seamless coordination of care between Critical Care and Emergency Medicine and continues to exceed our contractual obligations to enroll patients;2) To actively participate in the selection of the clinical trials to be performed by the PETAL network and to contribute to the subsequent responsibilities of the steering and other PETAL committees;3) To improve the conduct of clinical trials by facilitating the Institutional Review Board process;4) To maintain excellence and disseminate methodology to improve the quality of protocol compliance, data acquisition, and regulatory responsibilities across the PETAL network.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL123010-01
Application #
8705829
Study Section
Special Emphasis Panel (ZHL1-CSR-S (F1))
Program Officer
Harabin, Andrea L
Project Start
2014-06-17
Project End
2021-04-30
Budget Start
2014-06-17
Budget End
2015-04-30
Support Year
1
Fiscal Year
2014
Total Cost
$143,404
Indirect Cost
$50,811
Name
University of Colorado Denver
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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Clark, Brendan J; Moss, Marc (2016) The Acute Respiratory Distress Syndrome: Dialing in the Evidence? JAMA 315:759-61
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