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Pharmacological Management of Delirium (PMD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Regenstrief Institute, IU Center for Aging Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Malaz Boustani, MD, MPH, Regenstrief Institute, IU Center for Aging Research
ClinicalTrials.gov Identifier:
NCT00842608
First received: February 10, 2009
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Delirium
Cognitive Impairment
Behavioral: Reduced exposure to anticholinergics
Procedure: Reduced exposure to benzodiazepines
Drug: Haloperidol
Procedure: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Management of Delirium

Resource links provided by NLM:


Further study details as provided by Regenstrief Institute, IU Center for Aging Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 876
Study Start Date: February 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
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
Active Comparator: Haloperidol Eligible Usual Care
Usual care
Procedure: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
Experimental: Haldol-Ineligible Arm

Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.

Patients are randomized and will still receive:

reduced exposure to anticholinergics, reduced exposure to benzodiazepines

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
Active Comparator: Haldol Ineligible Usual Care
Usual Care
Procedure: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Prior history of severe mental illness
  • Alcohol-related delirium
  • Pregnant or nursing
  • Have had an aphasic stroke
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842608

Contacts
Contact: Teresa Smith, BS 317-274-9259 smithten@iupui.edu
Contact: Tiffany L Campbell, BS 317-274-9052 tiffcamp@iupui.edu

Locations
United States, Indiana
Eskenazi Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Malaz Boustani, MD    317-274-9235    mboustan@iupui.edu   
Contact: Tiffany Campbell, BS    317-274-9052    tiffcamp@iupui.edu   
Principal Investigator: Malaz Boustani, MD         
Methodist Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar A Khan, MD, MS    317-274-9132    bakhan@iupui.edu   
Contact: Tiffany L Campbell, BS    317-274-9052    tiffcamp@iupui.edu   
Principal Investigator: Malaz A Boustani, MD         
Sponsors and Collaborators
Regenstrief Institute, IU Center for Aging Research
Investigators
Principal Investigator: Malaz Boustani, MD Indiana University School of Medicine
  More Information

No publications provided by Regenstrief Institute, IU Center for Aging Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malaz Boustani, MD, MPH, Principal Investigator, Regenstrief Institute, IU Center for Aging Research
ClinicalTrials.gov Identifier: NCT00842608     History of Changes
Other Study ID Numbers: IA0145, R01AG034205
Study First Received: February 10, 2009
Last Updated: August 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Regenstrief Institute, IU Center for Aging Research:
confusion
dementia

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cognition Disorders
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cholinergic Antagonists
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014