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Pharmacological Management of Delirium (PMD)
This study is currently recruiting participants.
Study NCT00842608   Information provided by National Institute on Aging (NIA)
First Received: February 10, 2009   Last Updated: March 5, 2009   History of Changes

February 10, 2009
March 5, 2009
February 2009
June 2013   (final data collection date for primary outcome measure)
Delirium severity, days free of delirium and coma, measured by DRS-R-98, CAM-ICU, and RASS [ Time Frame: Daily ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842608 on ClinicalTrials.gov Archive Site
  • Length of stay [ Time Frame: end of ICU stay and hospital stay ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: ICU, in-hospital, 30-days post hospitalization ] [ Designated as safety issue: No ]
  • Hospital-acquired complications related to delirium or delirium management [ Time Frame: Daily ] [ Designated as safety issue: No ]
Same as current
 
Pharmacological Management of Delirium
Pharmacological Management of Delirium

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.

In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain failure that is an independent predictor of morbidity and mortality which often goes unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers and restraints, complications which 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 combination of 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.

Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory Problems;" see NCT00182832), a recently completed quality improvement project 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 the medical wards, which 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 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 as compared to usual care will have:

  • reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one 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
  • lower ICU, hospital, and 30-day mortality
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Delirium
  • Cognitive Impairment
  • Behavioral: Reduced exposure to anticholinergics
  • Procedure: Reduced exposure to benzodiazepines
  • Drug: Haloperidol
  • Procedure: Usual care
  • Experimental: Pharmacological interventions
  • Active Comparator: Usual care
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
428
June 2013
June 2013   (final data collection date for primary outcome measure)

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, QT prolongation of ≥ 500 ms in the absence of bundle branch block
  • History of allergic reaction to haloperidol
  • Prior history of severe mental illness
  • Alcohol-related delirium
  • Pregnant or nursing
Both
18 Years and older
No
 
United States
 
NCT00842608
Malaz Boustani, MD, MPH, Indiana University School of Medicine
IA0145, K23AG26770
National Institute on Aging (NIA)
 
Principal Investigator: Malaz Boustani, MD Indiana University School of Medicine
National Institute on Aging (NIA)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP