Critically ill patients are not benefiting from antipsychotic medications that have been used to treat delirium in intensive care units (ICUs) for more than four decades, according to a study released today in the New England Journal of Medicine.

Each year, more than 7 million hospitalized patients in the United States experience delirium, making them disoriented, withdrawn, drowsy or difficult to wake.

The large, multi-site MIND USA (Modifying the INcidence of Delirium) study sought to answer whether typical and atypical antipsychotics — haloperidol or ziprasidone — affected delirium, survival, length of stay or safety.

“We found, after extensive investigation with medical centers all over the country, that the patients who get these potentially dangerous drugs are not experiencing any improvements whatsoever in delirium, coma, length of stay or survival,” said senior author by E. Wesley Ely, MD, MPH, professor of Medicine at Vanderbilt University School of Medicine, associate director of Research for the VA Geriatric Research Education Clinical Center, and co-director of the CIBS (Critical Illness, Brain dysfunction, and Survivorship) Center at Vanderbilt University Medical Center.

Researchers screened nearly 21,000 patients at 16 U.S. medical centers. Of the 1,183 patients on mechanical ventilation or in shock, 566 became delirious and were randomized into groups receiving either intravenous haloperidol, ziprasidone or placebo (saline).

The investigators found no significant difference in duration of delirium or coma among participants on haloperidol or ziprasidone compared to placebo.

Similarly, there were no significant differences among participants on either antipsychotic medication compared to placebo in 30-day and 90-day mortality or time on the ventilator, or in the ICU and hospital.

“Every day, there are many thousands of patients receiving unnecessary antipsychotics in the critical care setting that are bringing risk and cost without benefit with respect to the outcomes measured in this NIA-sponsored MIND-USA study,” Ely said.

Ely’s companion ICU Liberation Collaborative investigation, released today by the Society of Critical Care Medicine, details how to streamline the best way to care for critically ill patients in the ICU by using the ABCDEF Bundle.

The study followed 15,000 patients at 70 medical centers across the United States and found that higher performance of the ABCDEF bundle saved lives, reduced length of stay, reduced delirium and coma, hospital readmissions and made patients less likely to be transferred to nursing homes, Ely said.

“In the ICU Liberation Collaborative investigation, we used a safety bundle much like what your airplane pilots use to help you get safely to your destination,” Ely said. “We try and provide the least amount of sedation to keep people safe and comfortable in the ICU while also managing their delirium, involving their families, getting them mobilized and walking around. ICU teams all over the world are working together to create a new culture of critical care for patients and families.”

The MIND USA study was funded by the National Institute on Aging, part of NIH, with grant AG035177. The ICU Liberation Collaborative was funded by the Gordon and Betty Moore Foundation through the Society of Critical Care Medicine (SCCM).

For more information go to www.icudelirium.org.