Pharmacological Management of Delirium (PMD)
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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 |
- 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 ]
- 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 |
|---|---|
|
Experimental: 1
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. 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 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: 2
Usual care
|
Procedure: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
|
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.
|
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 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
|
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 |
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
Contacts and Locations| Contact: Tiffany L Campbell, BS | 317-423-5605 | tiffcamp@iupui.edu |
| United States, Indiana | |
| Wishard Memorial Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Malaz Boustani, MD 317-423-5590 mboustan@iupui.edu | |
| Contact: Tiffany Campbell, BS 317-423-5605 tiffcamp@iupui.edu | |
| Principal Investigator: Malaz Boustani, MD | |
| 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, 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: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Regenstrief Institute, IU Center for Aging Research:
|
confusion dementia |
Additional relevant MeSH terms:
|
Delirium Delirium, Dementia, Amnestic, Cognitive Disorders Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Cognition Disorders Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Mental Disorders Haloperidol Haloperidol decanoate Cholinergic Antagonists Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Anti-Dyskinesia Agents Cholinergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013