REDUCE (haloperidol)
Trial question
What is the effect of haloperidol among critically ill patients with a high risk of delirium?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 1439
1439 patients (546 female, 893 male).
Inclusion criteria: critically ill adult patients at high risk of delirium whose ICU stay was at least a day.
Key exclusion criteria: delirium prior to inclusion; Parkinson's disease, history of acute neurological conditions; history of psychiatric disease and use of antipsychotic agents; known allergy or intolerance to haloperidol.
Interventions
N=732 haloperidol (2 mg intravenous infusion TID).
N=707 placebo (intravenous infusion of 0.9% sodium chloride TID).
Primary outcome
Days alive at 28 days
28 days
28 days
28.0 days
21.0 days
14.0 days
7.0 days
0.0 days
Haloperidol
Placebo
No significant
difference ↔
No significant difference in days alive at 28 days (28 days vs. 28 days).
Secondary outcomes
No significant difference in incidence of delirium at 28 days (33.3% vs. 33%; AD 0.4%, 95% CI -4.6 to 5.4).
Borderline significant increase in length of ICU stay (5 days vs. 4 days).
Borderline significant increase in days alive at 90 days (90 days vs. 90 days).
Safety outcomes
No significant difference in reported adverse events.
Conclusion
In critically ill adult patients at high risk of delirium whose ICU stay was at least a day, haloperidol was not superior to placebo with respect to days alive at 28 days.
Reference
Mark van den Boogaard, Arjen J C Slooter, Roger J M Brüggemann et al. Effect of Haloperidol on Survival Among Critically Ill Adults With a High Risk of Delirium: The REDUCE Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):680-690.
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