Delirium
Conditions
Keywords
Delirium, Mechanical ventilation, Intensive care, Haloperidol
Brief summary
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
Detailed description
Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.
Interventions
DRUGhaloperidol
Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.
OTHERSaline placebo
control arem
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult (\>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require \>24 hours of mechanical ventilation
Exclusion criteria
* Baseline QTc \>480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day All-cause Mortality | Daily |
| 90-day All-cause Mortality | 90 Days from enrollment in study |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Mechanical Ventilation | daily |
| ICU Length of Stay | Daily |
Participant flow
Recruitment details
This study was pre-maturely terminated and although sincere efforts were made to locate the relevant (and accurate) data for results reporting, limited data could be obtained and are reported in the Results section. Some data were either missing or were conflicting and were therefore, excluded.
Pre-assignment details
7 of 40 enrolled subjects never developed delirium, while 2 of 40 had persistent coma and died without ever opening eyes. Subjects were randomized to groups once the delirium was diagnosed. 31 subjects developed delirium and were eligible to randomized. 1 withdrew before starting/being randomized, as a result, 30 subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Haloperidol Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first. | 16 |
| Placebo Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Haloperidol | Placebo | Total |
|---|---|---|---|
| Age, Customized >=18 Years | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 2 / 13 |
| other Total, other adverse events | 16 / 16 | 12 / 13 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 |
Outcome results
Primary
28-day All-cause Mortality
Time frame: Daily
Population: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the Delirium, Persistent Coma, and No delirium.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delirium | 28-day All-cause Mortality | 4 Participants |
| Persistent Coma | 28-day All-cause Mortality | 2 Participants |
| No Delirium | 28-day All-cause Mortality | 1 Participants |
Primary
90-day All-cause Mortality
Time frame: 90 Days from enrollment in study
Population: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the Delirium, Persistent Coma, and No delirium.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delirium | 90-day All-cause Mortality | 4 Participants |
| Persistent Coma | 90-day All-cause Mortality | 2 Participants |
| No Delirium | 90-day All-cause Mortality | 1 Participants |
Secondary
Duration of Mechanical Ventilation
Time frame: daily
Population: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the Delirium, Persistent Coma, and No delirium.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Delirium | Duration of Mechanical Ventilation | 4.5 day |
| Persistent Coma | Duration of Mechanical Ventilation | 6 day |
| No Delirium | Duration of Mechanical Ventilation | 4 day |
Secondary
ICU Length of Stay
Time frame: Daily
Population: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the Delirium, Persistent Coma, and No delirium.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Delirium | ICU Length of Stay | 9 day |
| Persistent Coma | ICU Length of Stay | 6 day |
| No Delirium | ICU Length of Stay | 7 day |