Critically ill patients in intensive care units (ICUs), according to the National Institute on Aging, part of the National Institutes of Health. The multi-site team that conducted the trial found no evidence that treatment with antipsychotic medicines-haloperidol or ziprasidone-affected delirium, survival, length of ICU or hospital stay or safety.
The findings from the Modifying the Incidence of Delirium USA (MIND USA). The study was published in the New England Journal of Medicine.
"This is strong evidence from what we consider a 'gold standard' clinical trial showing that these two antipsychotics do not work to treat delirium during delirium. The evidence from this study suggests the need to reexamine that practice.
Delirium is an acute disturbance in attention and awareness with symptoms that can include disorganized thinking and agitation. More than 7 million hospitalized Americans per year experience delirium.
It can affect patients of any age but is more common among older adults who experience major illness especially involving ICU stay or have major surgery. Delirium is also associated with higher ICU costs and multiple adverse outcomes, such as longer hospital stays, long-term cognitive impairment, and death.
Antipsychotic medications have been used to treat delirium in ICU patients for 40 years without a definitive understanding of their effectiveness. To address the question of benefit versus risk of the use of antipsychotics for delirium.
Of the 1,183 patients on mechanical ventilation or in shock, 566 became delirious were randomized into three groups: those who received intravenous haloperidol, ziprasidone or placebo (saline).
Researchers found no significant difference in duration of delirium or coma among those participants on haloperidol or ziprasidone compared to placebo. Similarly, there were no significant differences between participants on either antipsychotic medication compared to placebo in 30-day and 90-day mortality or on the ventilator, or in the ICU and hospital.
The study population included participants with a wide range of ages, conditions and admission diagnoses. Overall, they had a 73-percent 30-day survival rate and 64% 90-day survival rate, which reflects the severe nature of their illnesses.
The research team also found no evidence of major harm from the antipsychotics but did note other research suggesting safety concerns including increased mortality associated with antipsychotic use in non-ICU geriatric populations.
This research joins other important studies on this complex condition. Large randomized trials like this can inform clinicians and help guide care.