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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00842608
First received: February 10, 2009
Last updated: February 3, 2017
Last verified: February 2017
Results First Received: November 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Delirium
Cognitive Impairment
Interventions: Behavioral: Reduced exposure to anticholinergics
Procedure: Reduced exposure to benzodiazepines
Drug: Haloperidol
Procedure: Usual care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
551 patients were consented into the study. After completing the consent and randomization, 6 patients withdrew from the study and were excluded from analysis. 545 patients consented to the study and completed the protocol.

Reporting Groups
  Description
Haloperidol Eligible Intervention

0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines

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

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

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

Haloperidol Eligible Usual Care

Usual care

Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

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

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

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

Haldol Ineligible Usual Care

Usual Care

Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium


Participant Flow:   Overall Study
    Haloperidol Eligible Intervention   Haloperidol Eligible Usual Care   Haldol-Ineligible Arm   Haldol Ineligible Usual Care
STARTED   170   176   99   100 
COMPLETED   170   176   99   100 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Haloperidol Eligible Intervention

0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines

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

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

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

Haloperidol Eligible Usual Care

Usual care

Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

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

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

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

Haldol Ineligible Usual Care

Usual Care

Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

Total Total of all reporting groups

Baseline Measures
   Haloperidol Eligible Intervention   Haloperidol Eligible Usual Care   Haldol-Ineligible Arm   Haldol Ineligible Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 170   176   99   100   545 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      109  64.1%      113  64.2%      57  57.6%      58  58.0%      337  61.8% 
>=65 years      61  35.9%      63  35.8%      42  42.4%      42  42.0%      208  38.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      98  57.6%      86  48.9%      65  65.7%      52  52.0%      301  55.2% 
Male      72  42.4%      90  51.1%      34  34.3%      48  48.0%      244  44.8% 
Region of Enrollment 
[Units: Participants]
         
United States   170   176   99   100   545 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Days Free of Delirium and Coma   [ Time Frame: Admission through day 8 of stay ]

2.  Secondary:   Hospital Length of Stay Post Randomization   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 11 days ]

3.  Secondary:   Mortality   [ Time Frame: ICU, in-hospital, 30-days post hospitalization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Malaz Boustani
Organization: Regenstrief Institute, Inc.
phone: (317) 274-9235
e-mail: mboustan@iu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT00842608     History of Changes
Other Study ID Numbers: IA0145
R01AG034205 ( US NIH Grant/Contract Award Number )
Study First Received: February 10, 2009
Results First Received: November 11, 2016
Last Updated: February 3, 2017