Trial record 1 of 1 for:    Pharmacological Management of Delirium (PMD)
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Pharmacological Management of Delirium (PMD)

This study is currently recruiting participants.
Verified September 2012 by Regenstrief Institute, IU Center for Aging Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Malaz Boustani, Regenstrief Institute, IU Center for Aging Research
ClinicalTrials.gov Identifier:
NCT00842608
First received: February 10, 2009
Last updated: September 20, 2012
Last verified: September 2012

February 10, 2009
September 20, 2012
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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Delirium
  • Cognitive Impairment
  • Behavioral: Reduced exposure to anticholinergics

    Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.

    Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol

  • Procedure: Reduced exposure to benzodiazepines
    Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
  • Drug: Haloperidol
    0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital
    Other Name: Haldol
  • Procedure: Usual care
    May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
  • Experimental: 1
    Pharmacological interventions
    Interventions:
    • Behavioral: Reduced exposure to anticholinergics
    • Procedure: Reduced exposure to benzodiazepines
    • Drug: Haloperidol
  • Active Comparator: 2
    Usual care
    Intervention: Procedure: Usual care
  • Experimental: Arm 3
    Non-Haldol arm for patients with prolonged QT or history of seizures. Patients are randomized and will still receive benzo & anticholinergic drug reduction in intervention arm, but will not receive Haldol.
    Interventions:
    • Behavioral: Reduced exposure to anticholinergics
    • Procedure: Reduced exposure to benzodiazepines
Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, Abernathy G, Buckley J, Sing R, Tricker J, Zawahiri M, Boustani MA. Improving delirium care in the intensive care unit: the design of a pragmatic study. Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
  • History of allergic reaction to haloperidol
  • Prior history of severe mental illness
  • Alcohol-related delirium
  • Pregnant or nursing
  • Have had an aphasic stroke
Both
18 Years and older
No
Contact: Tiffany L Campbell, BS 317-423-5605 tiffcamp@iupui.edu
United States
 
NCT00842608
IA0145, R01AG034205
Yes
Malaz Boustani, Regenstrief Institute, IU Center for Aging Research
Regenstrief Institute, IU Center for Aging Research
National Institute on Aging (NIA)
Principal Investigator: Malaz Boustani, MD Indiana University School of Medicine
Regenstrief Institute, IU Center for Aging Research
September 2012

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