Author Contributions: Drs Pandharipande and Ely had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Pandharipande, Pun, Maze, Girard, Shintani, Jackson, Deppen, Stiles, Dittus, Bernard, and Ely.
Acquisition of data: Pandharipande, Pun, Herr, Girard, Miller, Jackson, Deppen, Stiles, and Ely.
Analysis and interpretation of data: Pandharipande, Pun, Herr, Maze, Girard, Miller, Shintani, Thompson, Jackson, Deppen, Stiles, Dittus, Bernard, and Ely.
Drafting of the manuscript: Pandharipande, Pun, Herr, Maze, Girard, Miller, Shintani, Thompson, and Ely.
Critical revision of the manuscript for important intellectual content: Pandharipande, Herr, Maze, Girard, Jackson, Deppen, Stiles, Dittus, Bernard, and Ely.
Statistical analysis: Shintani and Thompson.
Administrative, technical, or material support: Jackson.
Study supervision: Pandharipande, Herr, and Ely.
Financial Disclosures: Drs Pandharipande, Herr, Maze, and Girard and Ms Pun have received research grants or honoraria from Hospira Inc. Dr Ely has received research grants and honoraria from Hospira, Inc, Pfizer, and Eli Lilly, and a research grant from Aspect Medical Systems. The other authors report no financial disclosures.
Funding/Support: This investigator-initiated study was aided by receipt of study drug and an unrestricted research grant for laboratory and investigational studies from Hospira Inc. Dr Pandharipande is the recipient of the ASCCA-FAER-Abbott Physician Scientist Award and the Vanderbilt Physician Scientist Development Award. Dr Girard is supported by the Hartford Geriatrics Health Outcomes Research Scholars Award Program and the Vanderbilt Physician Scientist Development Program. Dr Ely is supported by the VA Clinical Science Research and Development Service (VA Merit Review Award) and a grant from the National Institutes of Health (AG0727201).
Role of the Sponsor: Hospira Inc (Lake Forest, Illinois) provided dexmedetomidine as well as funds for safety laboratory studies and electrocardiograms (requested by the FDA). Hospira Inc had no role in the design or conduct of the study; in the collection, analysis, and interpretation of the data; in the preparation, review, or approval of this manuscript; or in the publication strategy of the results of this study. These data are not being used to generate FDA label changes for this medication, but rather to advance the science of sedation, analgesia, and brain dysfunction in critically ill patients.