Tyree H Kiser1, Jonathan E Sevransky2, Jerry A Krishnan3, James Tonascia4, Robert A Wise5, William Checkley5, John Walsh6,7, Jamie B Sullivan6, Kevin C Wilson8, Alan Barker8, Marc Moss9, R William Vandivier9,10. 1. Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora. 2. Division of Pulmonary and Critical Care Medicine, Emory University, Atlanta, Georgia. 3. Population Health Sciences Program, University of Illinois Hospital and Health Sciences System, Chicago. 4. Department of Epidemiology and Biostatistics, School of Medicine, Johns Hopkins University, Baltimore, Maryland. 5. Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland. 6. COPD Foundation, Washington D.C. 7. Died March 7, 2017. 8. The Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts and Official Documents Department, American Thoracic Society, New York, New York. 9. Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora. 10. for the DECIDE Investigators: DECIDE - DosE of CorticosteroIDs for Exacerbations of COPD.
Abstract
Background: For over 40 years, systemic corticosteroids have been a mainstay of treatment for patients with exacerbations of chronic obstructive pulmonary disease (COPD). Surprisingly, the optimal dosage of corticosteroids is unknown in critically ill patients requiring assisted ventilation, a group with high morbidity and mortality. Methods: We surveyed 39 academic physicians within the United States Critical Illness and Injury Trials Group (USCIITG) and the Prevention and Early Treatment of Acute Lung Injury Trials Network (PETAL) to determine the range of corticosteroid dosages used to treat patients with COPD exacerbations requiring assisted ventilation. We also asked if these physicians believe that a clinical trial is needed to determine the optimal dosage of corticosteroids in this population. Results: Thirty-two physicians (82%) responded to the survey. Usual practice was to start intravenous methylprednisolone at a median dose of 120 mg/day (range 40-500 mg/day). In the context of a clinical trial, 78% of physicians were comfortable initiating methylprednisolone at a dose as low as 40 mg/day. In contrast, physicians were split on the highest acceptable methylprednisolone dose, with 44% comfortable initiating doses as high as 500 mg/day, 44% at 240 mg/day, and 12% at doses less than 240 mg/day. Ninety-four percent of respondents believed that a randomized controlled trial is needed to determine the optimal corticosteroid dose to treat patients with COPD exacerbations requiring assisted ventilation. Conclusions: These results demonstrate sufficient clinical equipoise to support the conduct of a clinical trial to identify the optimal dose of systemic corticosteroids for patients with COPD exacerbations requiring assisted ventilation.
Background: For over 40 years, systemic corticosteroids have been a mainstay of treatment for patients with exacerbations of chronic obstructive pulmonary disease (COPD). Surprisingly, the optimal dosage of corticosteroids is unknown in critically illpatients requiring assisted ventilation, a group with high morbidity and mortality. Methods: We surveyed 39 academic physicians within the United States Critical Illness and Injury Trials Group (USCIITG) and the Prevention and Early Treatment of Acute Lung Injury Trials Network (PETAL) to determine the range of corticosteroid dosages used to treat patients with COPD exacerbations requiring assisted ventilation. We also asked if these physicians believe that a clinical trial is needed to determine the optimal dosage of corticosteroids in this population. Results: Thirty-two physicians (82%) responded to the survey. Usual practice was to start intravenous methylprednisolone at a median dose of 120 mg/day (range 40-500 mg/day). In the context of a clinical trial, 78% of physicians were comfortable initiating methylprednisolone at a dose as low as 40 mg/day. In contrast, physicians were split on the highest acceptable methylprednisolone dose, with 44% comfortable initiating doses as high as 500 mg/day, 44% at 240 mg/day, and 12% at doses less than 240 mg/day. Ninety-four percent of respondents believed that a randomized controlled trial is needed to determine the optimal corticosteroid dose to treat patients with COPD exacerbations requiring assisted ventilation. Conclusions: These results demonstrate sufficient clinical equipoise to support the conduct of a clinical trial to identify the optimal dose of systemic corticosteroids for patients with COPD exacerbations requiring assisted ventilation.
Authors: Diego Bonilla Arcos; Jerry A Krishnan; R William Vandivier; Jonathan E Sevransky; William Checkley; Tyree H Kiser; Jamie L Sullivan; John W Walsh; Robert A Wise; Kevin C Wilson Journal: Chronic Obstr Pulm Dis Date: 2016-02-17
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