Advancing donor management research: design and implementation of a large, randomized, placebo-controlled trial

Persistent Link:
http://hdl.handle.net/10150/610331
Title:
Advancing donor management research: design and implementation of a large, randomized, placebo-controlled trial
Author:
Ware, Lorraine; Koyama, Tatsuki; Billheimer, Dean; Landeck, Megan; Johnson, Elizabeth; Brady, Sandra; Bernard, Gordon; Matthay, Michael
Affiliation:
Division 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
Issue Date:
2011
Publisher:
BioMed Central
Citation:
Ware et al. Annals of Intensive Care 2011, 1:20 http://www.annalsofintensivecare.com/content/1/1/20
Journal:
Annals 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)
Collection Information:
This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
Abstract:
BACKGROUND: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.
EISSN:
2110-5820
DOI:
10.1186/2110-5820-1-20
Version:
Final published version
Additional Links:
http://www.annalsofintensivecare.com/content/1/1/20

Full metadata record

DC FieldValue Language
dc.contributor.authorWare, Lorraineen
dc.contributor.authorKoyama, Tatsukien
dc.contributor.authorBillheimer, Deanen
dc.contributor.authorLandeck, Meganen
dc.contributor.authorJohnson, Elizabethen
dc.contributor.authorBrady, Sandraen
dc.contributor.authorBernard, Gordonen
dc.contributor.authorMatthay, Michaelen
dc.date.accessioned2016-05-20T09:04:24Z-
dc.date.available2016-05-20T09:04:24Z-
dc.date.issued2011en
dc.identifier.citationWare et al. Annals of Intensive Care 2011, 1:20 http://www.annalsofintensivecare.com/content/1/1/20en
dc.identifier.doi10.1186/2110-5820-1-20en
dc.identifier.urihttp://hdl.handle.net/10150/610331-
dc.description.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.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.annalsofintensivecare.com/content/1/1/20en
dc.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)en
dc.titleAdvancing donor management research: design and implementation of a large, randomized, placebo-controlled trialen
dc.typeArticleen
dc.identifier.eissn2110-5820en
dc.contributor.departmentDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN, USAen
dc.contributor.departmentDepartment of Biostatistics, Vanderbilt University, Nashville, TN, USAen
dc.contributor.departmentBIO5 Institute, the University of Arizona, Tucson, AZ, USAen
dc.contributor.departmentCalifornia Transplant Donor Network, Oakland, CA, USAen
dc.contributor.departmentDepartment of Medicine, University of California, San Francisco, CA, USAen
dc.contributor.departmentDepartment of Anesthesia, University of California, San Francisco, CA, USAen
dc.contributor.departmentCardiovascular Research Institute, University of California, San Francisco, CA, USAen
dc.identifier.journalAnnals of Intensive Careen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
All Items in UA Campus Repository are protected by copyright, with all rights reserved, unless otherwise indicated.