Skip to main content

Pharmacological Management of Delirium (PMD)

  • Completed

The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the intensive care unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years N/A Both No
February 2009
June 2015
428

++18 years of age or older ++Hospitalized on an ICU ward ++Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay ++English speaking

++Admitted directly to a regular non-ICU ward++Previously enrolled in the study++Not eligible for delirium assessment as determined by RASS scores++Contraindications for use of haloperidol, such as history of torsades-de-pointes or allergic reaction to haloperidol++Prior history of severe mental illness++Alcohol-related delirium++Pregnant or nursing++Have had an aphasic stroke

In 2005, approximately 2.7 million Americans aged 65 and older spent at least 1 day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that up to 80% of these older ICU patients had delirium, an often unrecognized acute brain failure that is an independent predictor of morbidity and mortality, during their hospital stay. Older adults with delirium are more prone to falls, injuries, and other complications that may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, and higher health care costs.

The literature supports treatment with a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications. This study will test a more targeted pharmacologic approach to the care of older adults with delirium, while still recognizing the clinicians' role in controlling symptoms and providing intensive care.

The hypothesis is that patients in the intervention arm, compared to those receiving usual care, will have reduced delirium severity, fewer hospital days with delirium or coma, shorter hospital lengths of stay, and lower ICU, hospital, and 30-day mortality.

Name City State Zip Status Primary Contact
Eskenazi Hospital Indianapolis Indiana 46202

Methodist Hospital Indianapolis Indiana 46202

University Hospital Indianapolis Indiana 46202

Regenstrief Institute, IU Center for Aging Research

  • National Institute on Aging (NIA) - NIH

Name Role Affiliation
Malaz Boustani, MD Principal Investigator Indiana University School of Medicine

Name Phone Extension Email
Tiffany L. Campbell 317-423-5605 tiffcamp@iupui.edu

Pharmacological Management of Delirium