Pharmacological Management of Delirium (PMD)
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| ClinicalTrials.gov Identifier: NCT00842608 |
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Recruitment Status :
Completed
First Posted : February 12, 2009
Results First Posted : March 24, 2017
Last Update Posted : August 17, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Delirium Cognitive Impairment | Behavioral: Reduced exposure to anticholinergics Procedure: Reduced exposure to benzodiazepines Drug: Haloperidol Procedure: Usual care | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 551 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Pharmacological Management of Delirium |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
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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 |
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Active Comparator: Haloperidol Eligible Usual Care
Usual care
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Procedure: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
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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 |
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Active Comparator: Haldol Ineligible Usual Care
Usual Care
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Procedure: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
- Days Free of Delirium and Coma [ Time Frame: Admission through day 8 of stay ]
- Hospital Length of Stay Post Randomization [ Time Frame: Participants were followed for the duration of hospital stay, an average of 11 days ]
- Mortality [ Time Frame: ICU, in-hospital, 30-days post hospitalization ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
- Prior history of severe mental illness
- Alcohol-related delirium
- Pregnant or nursing
- Have had an aphasic stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842608
| United States, Indiana | |
| Eskenazi Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Malaz Boustani, MD | Indiana University School of Medicine |
| Responsible Party: | MALAZ BOUSTANI, Principal Investigator, Regenstrief Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT00842608 |
| Other Study ID Numbers: |
IA0145 R01AG034205 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 12, 2009 Key Record Dates |
| Results First Posted: | March 24, 2017 |
| Last Update Posted: | August 17, 2018 |
| Last Verified: | August 2018 |
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confusion dementia |
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Delirium Neurocognitive Disorders Mental Disorders Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Haloperidol Haloperidol decanoate Cholinergic Antagonists Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cholinergic Agents |