Pharmacological Management of Delirium - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00842608

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Pharmacological Management of Delirium

Resource links provided by NLM:

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

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:	428
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pharmacological interventions	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. 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
2: Active Comparator Usual care	Procedure: Usual care May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

Arms

Assigned Interventions

1: Experimental

Pharmacological interventions

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.

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

2: Active Comparator

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
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

Contacts and Locations

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

Locations

United States, Indiana
Wishard Memorial Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Malaz Boustani, MD 317-423-5590 mboustani@regenstrief.org
Contact: Tiffany Campbell 317-423-5605 tdyar@regenstrief.org
Principal Investigator: Malaz Boustani, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Malaz Boustani, MD

Indiana University School of Medicine

More Information

No publications provided

Responsible Party:	Indiana University School of Medicine ( Malaz Boustani, MD, MPH )
Study ID Numbers:	IA0145, K23AG26770
Study First Received:	February 10, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00842608 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

confusion
dementia

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Cholinergic Agents
Haloperidol
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Neurobehavioral Manifestations
Delirium
Tranquilizing Agents

Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Confusion
Dopamine Antagonists
Antipsychotic Agents
Cognition Disorders
Pharmacologic Actions
Haloperidol decanoate
Delirium, Dementia, Amnestic, Cognitive Disorders
Autonomic Agents
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009