Alzheimer's Disease Education and Referral Center

Pharmacological Management of Delirium (PMD)

Pharmacological Management of Delirium (PMD)

Overall Status: 
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
18 Years
Inclusion Criteria: 

  • 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

Exclusion Criteria: 

  • 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

Detailed Description: 

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.

Map Marker CityStateZip CodePrimary Contact

Geolocation is 39.7794767, -86.1700894

Eskenazi Hospital

Geolocation is 39.7794767, -86.1700894

Methodist Hospital

Geolocation is 39.7794767, -86.1700894

University Hospital
Lead Sponsor: 
Regenstrief Institute, IU Center for Aging Research
Collaborator Sponsor: 
National Institute on Aging (NIA)
Facility Investigators: 
Malaz Boustani, MD
Principal Investigator
Indiana University School of Medicine
Study Contact: 
Tiffany L. Campbell
Locations ID 
NCT00842608 (follow link to view full record on in new window)
Official Title: 
Pharmacological Management of Delirium
Study Start Date: 
February 2009
Study End Date: 
June 2015