Alzheimer's Disease Education and Referral Center

Pharmacological Management of Delirium (PMD)

Pharmacological Management of Delirium (PMD)

Overall Status: 
Recruiting
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
N/A
Both
No
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, pressure ulcers, and restraints, complications that may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased institutionalization, 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.

The e-CHAMP study ("Enhancing Care for Hospitalized Older Adults With Memory Problems"; see NCT00182832) tested the effectiveness of cognitive screening coupled with computerized decision support in reducing delirium and other hospital-related complications among 424 older adults hospitalized on medical wards. It found that many of the older adults entering the study had already experienced delirium in the ICU prior to their transfer to the wards.

This study will test a pharmacologic intervention that allows 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, as measured by the Delirium Rating Scale (DRS-R-98), at 1 week following randomization or hospital discharge; fewer hospital days with delirium or coma, as determined by the Confusion Assessment Method in the ICU (CAM-ICU); shorter hospital lengths of stay; and lower ICU, hospital, and 30-day mortality.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 39.7794767, -86.1700894

Wishard Memorial Hospital
Indianapolis
Indiana
46202
Recruiting
Malaz Boustani, MD
317-423-5590
mboustan@iupui.edu
Lead Sponsor: 
Agency
Regenstrief Institute, IU Center for Aging Research
Collaborator Sponsor: 
Agency
National Institute on Aging (NIA)
Facility Investigators: 
NameRoleAffiliation
Malaz Boustani, MD
Principal Investigator
Indiana University School of Medicine
Study Contact: 
NamePhoneEmail
Tiffany L. Campbell
317-423-5605
Locations
 
 
ClinicalTrials.gov ID 
NCT00842608 (follow link to view full record on ct.gov in new window)
Official Title: 
Pharmacological Management of Delirium
Study Start Date: 
February 2009
Study End Date: 
June 2014
Enrollment: 
428