Nashville, TN—Giving haloperidol and ziprasidone to critically ill patients who develop delirium does not have the intended effect of controlling the condition in hospital ICUs, a new study reveals.
The report in the New England Journal of Medicine notes that no evidence was found that the antipsychotic medicines affected delirium, survival, safety, or the length of ICU or hospital stay. Those findings have the potential to change the 40-year-old practice of using the drugs to treat delirium in ICU patients.
Modifying the Incidence of Delirium USA (MIND USA) researchers point out that no significant difference was documented in duration of delirium or coma among those participants on haloperidol or ziprasidone compared with placebo. In addition, no significant benefit was found for either antipsychotic medication compared with placebo in 30-day and 90-day mortality or time on a ventilator, or in the ICU and hospital.
“This is strong evidence from what we consider a ‘gold standard’ clinical trial showing that these two antipsychotics don’t work to treat delirium during a critical illness,” explained Deputy Director Marie A. Bernard, MD, of the National Institute on Aging, which funded the study. “Antipsychotics have often been used to treat delirium. The evidence from this study suggests the need to reexamine that practice.”
The findings are contrary to decades of practice. Background information in the article states that antipsychotic medications have been used to treat delirium in ICU patients for four decades without definitive understanding of their effectiveness.
The MIND USA investigators were led by E. Wesley Ely, MD, MPH, professor of medicine at Vanderbilt University Medical Center, associate director of Research for the Veterans Affairs Geriatric Research Education Clinical Center, and codirector of the CIBS (Critical Illness, Brain dysfunction, and Survivorship) Center.
Ely and colleagues screened nearly 21,000 patients at 16 U.S. medical centers, all of whom were either on mechanical ventilation or in shock. Of those, 566 became delirious and were randomized into three groups by the treatment they received—either IV haloperidol, ziprasidone, or placebo (saline). The researchers then measured for endpoints including delirium and coma duration, time on mechanical ventilation, successful discharge from ICU and hospital, as well as 30- and 90-day mortality.
The severely ill participants, who varied greatly in terms of age, conditions, and admission diagnoses, had a 73% 30-day survival rate and a 64% 90-day survival rate. The study authors found no evidence of major harm from the antipsychotics but cited other research suggesting safety concerns—including increased mortality—associated with antipsychotic use in non-ICU geriatric populations.
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The report in the New England Journal of Medicine notes that no evidence was found that the antipsychotic medicines affected delirium, survival, safety, or the length of ICU or hospital stay. Those findings have the potential to change the 40-year-old practice of using the drugs to treat delirium in ICU patients.
Modifying the Incidence of Delirium USA (MIND USA) researchers point out that no significant difference was documented in duration of delirium or coma among those participants on haloperidol or ziprasidone compared with placebo. In addition, no significant benefit was found for either antipsychotic medication compared with placebo in 30-day and 90-day mortality or time on a ventilator, or in the ICU and hospital.
“This is strong evidence from what we consider a ‘gold standard’ clinical trial showing that these two antipsychotics don’t work to treat delirium during a critical illness,” explained Deputy Director Marie A. Bernard, MD, of the National Institute on Aging, which funded the study. “Antipsychotics have often been used to treat delirium. The evidence from this study suggests the need to reexamine that practice.”
The findings are contrary to decades of practice. Background information in the article states that antipsychotic medications have been used to treat delirium in ICU patients for four decades without definitive understanding of their effectiveness.
The MIND USA investigators were led by E. Wesley Ely, MD, MPH, professor of medicine at Vanderbilt University Medical Center, associate director of Research for the Veterans Affairs Geriatric Research Education Clinical Center, and codirector of the CIBS (Critical Illness, Brain dysfunction, and Survivorship) Center.
Ely and colleagues screened nearly 21,000 patients at 16 U.S. medical centers, all of whom were either on mechanical ventilation or in shock. Of those, 566 became delirious and were randomized into three groups by the treatment they received—either IV haloperidol, ziprasidone, or placebo (saline). The researchers then measured for endpoints including delirium and coma duration, time on mechanical ventilation, successful discharge from ICU and hospital, as well as 30- and 90-day mortality.
The severely ill participants, who varied greatly in terms of age, conditions, and admission diagnoses, had a 73% 30-day survival rate and a 64% 90-day survival rate. The study authors found no evidence of major harm from the antipsychotics but cited other research suggesting safety concerns—including increased mortality—associated with antipsychotic use in non-ICU geriatric populations.
« Click here to return to Weekly News Update.
