AID-ICU
Trial question
What is the role of haloperidol in acutely admitted adult ICU patients with delirium?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 987
987 patients (343 female, 644 male)
Inclusion criteria: acutely admitted adult ICU patients with delirium
Key exclusion criteria: known contraindications to haloperidol; habitual treatment with any antipsychotic medication or treatment with antipsychotics in the ICU before screening; dementia or mental retardation; delirium assessment non-applicable
Interventions
N=501 haloperidol (intravenous dose of 2.5 mg TID and additional as-needed doses to a maximum daily dose of 20 mg)
N=486 placebo (intravenous isotonic saline TID)
Primary outcome
Rate of 1-year mortality
44.7
51.6
51.6 %
38.7 %
25.8 %
12.9 %
0.0 %
Haloperidol
Placebo
Significant decrease ▼
NNT = 14
Significant decrease in the rate of 1-year mortality (44.7% vs. 51.6%; ARD -6.4, 95% CI -12.8 to -0.2)
Secondary outcomes
No significant difference in EuroQol 5-domain 5-level Index values in survivors (0.85 vs. 0.81 ; RR 1, 95% CI 0.86 to 1.15)
No significant difference in EuroQol VAS (25 vs. 0 ; AD 25 , 95% CI -8.35 to 58.35)
No significant difference in EuroQol VAS in survivors (70 vs. 75 ; AD -5 , 95% CI -509.74 to 499.74)
Conclusion
In acutely admitted adult ICU patients with delirium, haloperidol was superior to placebo with respect to the rate of 1-year mortality.
Reference
Camilla Bekker Mortensen, Nina Christine Andersen-Ranberg, Lone Musaeus Poulsen et al. Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium. Intensive Care Med. 2024 Jan;50(1):103-113.
Open reference URL