Functional Status After Delirium in the ICU: A 1-Year Follow-Up of the Agents Intervening Against Delirium in the ICU (AID-ICU) Trial

Objectives: To assess the effect of haloperidol compared with placebo on functional status in adult ICU patients with delirium, 1 year after inclusion in the Agents Intervening against Delirium in the ICU (AID-ICU) trial. Design: This was a preplanned 1-year follow-up of the randomized, placebo-controlled, blinded AID-ICU trial. Setting and Patients: A total of 632 Danish patients enrolled in the AID-ICU trial at three selected Danish sites. Interventions: None. Measurements and Main Results: Functional status was evaluated using the Lawton-Brody Instrumental Activities of Daily Living (IADL) score, the Barthel-20 Activities of Daily Living (ADL) score, the Clinical Frailty Scale (CFS), and grip strength. Nonsurvivors were assigned the worst possible values, and missing data were managed with multiple imputation. Results were presented as mean differences and ratios of means with 95% CIs, adjusted for age, and sex. Of the original cohort of 632 patients enrolled in the AID-ICU trial at the three Danish sites, 75 participants in the haloperidol group, and 69 in the placebo group were available for follow-up. In 28.5% of responders (41/144), follow-up was performed by telephone. The proportion of relatives answering the questionnaire at 1-year follow-up on behalf of the participants was 4.2% (6/144). At 1 year, the adjusted mean differences between IADL, ADL, CFS, and grip strength in the haloperidol and placebo group were 0.1 (95% CI, –0.5 to 0.7; p = 0.687), 0.2 (95% CI, –1.3 to 1.7; p = 0.773), 0.0 (95% CI, –0.4 to 0.5; p = 0.862), and –2.9 (95% CI, –7.1 to 1.2; p = 0.175), respectively. Conclusions: Among adult ICU patients with delirium, treatment with haloperidol vs. placebo did not result in statistically significant differences in functional status at 1-year follow-up. However, due to the uncertainty of the estimates, clinically important differences cannot be excluded.