Advancing donor management research: design and implementation of a large, randomized, placebo-controlled trial
AffiliationDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN, USA
Department of Biostatistics, Vanderbilt University, Nashville, TN, USA
BIO5 Institute, the University of Arizona, Tucson, AZ, USA
California Transplant Donor Network, Oakland, CA, USA
Department of Medicine, University of California, San Francisco, CA, USA
Department of Anesthesia, University of California, San Francisco, CA, USA
Cardiovascular Research Institute, University of California, San Francisco, CA, USA
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CitationWare et al. Annals of Intensive Care 2011, 1:20 http://www.annalsofintensivecare.com/content/1/1/20
JournalAnnals of Intensive Care
Rights© 2011 Ware et al; licensee Springer. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
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AbstractBACKGROUND:Given the persistent shortage of organs for transplantation, new donor management strategies to improve both organ utilization and quality of procured organs are needed. Current management protocols for the care of the deceased donor before organ procurement are based on physiological rationale, experiential reasoning, and retrospective studies without rigorous testing. Although many factors contribute to the lack of controlled clinical trials in donor management, a major factor is the unique challenges posed by research in the brain-dead organ donor.METHODS AND RESULTS:This article describes the study design and the challenges faced during implementation of the Beta-agonists for Oxygenation in Lung Donors (BOLD) study, a randomized, placebo-controlled clinical trial of nebulized albuterol vs. placebo in 500 organ donors. The study design and implementation are described with emphasis on aspects of the study that are unique to research in brain-dead organ donors.CONCLUSIONS:Experience gained during the design and implementation of the BOLD study should be useful for investigators planning future clinical trials in the brain-dead donor population and for intensivists who are involved in the care of the brain-dead organ donor.
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