Trial Outcomes & Findings for Pharmacological Management of Delirium (NCT NCT00842608)
NCT ID: NCT00842608
Last Updated: 2018-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
551 participants
Primary outcome timeframe
Admission through day 8 of stay
Results posted on
2018-08-17
Participant Flow
551 patients were consented into the study. After completing the consent and randomization, 6 patients withdrew from the study and were included in intention-to-treat analysis. 545 patients completed the protocol.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
174
|
177
|
99
|
101
|
|
Overall Study
COMPLETED
|
170
|
176
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological Management of Delirium
Baseline characteristics by cohort
| Measure |
Haloperidol Eligible Intervention
n=174 Participants
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
n=177 Participants
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
n=99 Participants
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
n=101 Participants
Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
Total
n=551 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
342 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
209 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
302 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
249 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
174 participants
n=99 Participants
|
177 participants
n=107 Participants
|
99 participants
n=206 Participants
|
101 participants
n=7 Participants
|
551 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Admission through day 8 of stayOutcome measures
| Measure |
Haloperidol Eligible Intervention
n=174 Participants
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
n=177 Participants
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
n=99 Participants
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
n=101 Participants
Usual Care
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
|
4 days
Interval 2.0 to 7.0
|
5 days
Interval 1.0 to 7.0
|
4 days
Interval 1.0 to 7.0
|
5 days
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of hospital stay, an average of 11 daysOutcome measures
| Measure |
Haloperidol Eligible Intervention
n=174 Participants
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
n=177 Participants
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
n=99 Participants
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
n=101 Participants
Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
|---|---|---|---|---|
|
Hospital Length of Stay Post Randomization
|
20.2 days
Standard Deviation 33.5
|
18.6 days
Standard Deviation 31.6
|
18.8 days
Standard Deviation 17.1
|
14.9 days
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: ICU, in-hospital, 30-days post hospitalizationOutcome measures
| Measure |
Haloperidol Eligible Intervention
n=174 Participants
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
n=177 Participants
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
n=99 Participants
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
n=101 Participants
Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
|---|---|---|---|---|
|
Mortality
|
20 Participants
|
32 Participants
|
11 Participants
|
8 Participants
|
Adverse Events
Haloperidol Eligible Intervention
Serious events: 45 serious events
Other events: 87 other events
Deaths: 0 deaths
Haloperidol Eligible Usual Care
Serious events: 57 serious events
Other events: 82 other events
Deaths: 0 deaths
Haldol-Ineligible Arm
Serious events: 27 serious events
Other events: 63 other events
Deaths: 0 deaths
Haldol Ineligible Usual Care
Serious events: 22 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Haloperidol Eligible Intervention
n=174 participants at risk
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
n=177 participants at risk
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
n=99 participants at risk
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
n=101 participants at risk
Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
|---|---|---|---|---|
|
Nervous system disorders
Patients with CNS
|
2.9%
5/174
|
4.0%
7/177
|
4.0%
4/99
|
2.0%
2/101
|
|
Cardiac disorders
Patients with Cardiovascular
|
8.0%
14/174
|
11.3%
20/177
|
10.1%
10/99
|
8.9%
9/101
|
|
Respiratory, thoracic and mediastinal disorders
Patients with Respiratory
|
13.2%
23/174
|
17.5%
31/177
|
11.1%
11/99
|
11.9%
12/101
|
|
Gastrointestinal disorders
Patients with GI
|
3.4%
6/174
|
3.4%
6/177
|
3.0%
3/99
|
3.0%
3/101
|
|
Renal and urinary disorders
Patients with GU
|
4.0%
7/174
|
2.3%
4/177
|
0.00%
0/99
|
4.0%
4/101
|
|
Skin and subcutaneous tissue disorders
Patients with Skin
|
1.1%
2/174
|
1.1%
2/177
|
1.0%
1/99
|
0.00%
0/101
|
|
Hepatobiliary disorders
Patients with Hepatic
|
2.3%
4/174
|
1.7%
3/177
|
0.00%
0/99
|
0.00%
0/101
|
|
Blood and lymphatic system disorders
Patients with Hematologic
|
6.9%
12/174
|
7.9%
14/177
|
3.0%
3/99
|
3.0%
3/101
|
|
Endocrine disorders
Patients with Endocrine
|
0.57%
1/174
|
0.56%
1/177
|
0.00%
0/99
|
0.00%
0/101
|
|
Musculoskeletal and connective tissue disorders
Patients with Musculoskeletal
|
1.1%
2/174
|
0.56%
1/177
|
1.0%
1/99
|
0.99%
1/101
|
|
Investigations
Other
|
4.0%
7/174
|
0.00%
0/177
|
4.0%
4/99
|
0.00%
0/101
|
Other adverse events
| Measure |
Haloperidol Eligible Intervention
n=174 participants at risk
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
n=177 participants at risk
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
n=99 participants at risk
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
n=101 participants at risk
Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
|---|---|---|---|---|
|
General disorders
General Events
|
50.0%
87/174
|
46.3%
82/177
|
63.6%
63/99
|
58.4%
59/101
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place