In just two weeks from 2/1/2012 The University of Iowa Hospitals and Clinics (UIHC) will begin recruiting subjects for a major study designed to investigate preventing and treating delirium in intensive care unit (ICU) patients. It’s called The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study. The UIHC is one of 13 states, 15 academic medical centers in America participating in the interventional, randomized, placebo-controlled trial to study the safety and efficacy of Haloperidol and Ziprasidone compared to placebo in managing delirium in critical care units. Neither of the antipsychotic study drugs in that trial was helpful or harmful .
The study sponsor is Vanderbilt University Medical Center in Nashville, Tennessee, led by principal investigator Dr. E. Wesley Ely, MD. The UIHC principal investigator is Dr. Gregory A. Schmidt, MD.
The previous, similar MIND (Modifying the Incidence of Delirium) Study in which UIHC also collaborated was a feasibility study which found that a study of the type now being undertaken is possible. In that study, Haloperidol and Ziprasidone were also compared against placebo.
The study will enroll hundreds of patients and the ultimate goal is to advance our understanding of the role of antipsychotic medications in delirium prevention and treatment in the ICU. It will also likely have major implications for the management and prevention of delirium in non-ICU hospital units as well.
You can read more about the MIND Study at link http://clinicaltrials.gov/ct2/show/NCT01211522?term=modifying+the+incidence+of+neurological+dysfunction&rank=1.
Girard, T. D., P. P. Pandharipande, et al. (2010). “Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo-controlled trial.” Crit Care Med 38(2): 428-437.
OBJECTIVE: To demonstrate the feasibility of a placebo-controlled trial of antipsychotics for delirium in the intensive care unit and to test the hypothesis that antipsychotics would improve days alive without delirium or coma. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Six tertiary care medical centers in the US. PATIENTS: One hundred one mechanically ventilated medical and surgical intensive care unit patients. INTERVENTION: Patients were randomly assigned to receive haloperidol or ziprasidone or placebo every 6 hrs for up to 14 days. Twice each day, frequency of study drug administration was adjusted according to delirium status, level of sedation, and side effects. MEASUREMENTS AND MAIN OUTCOMES: The primary end point was the number of days patients were alive without delirium or coma. During the 21-day study period, patients in the haloperidol group spent a similar number days alive without delirium or coma (median [interquartile range], 14.0 [6.0-18.0] days) as did patients in the ziprasidone (15.0 [9.1-18.0] days) and placebo groups (12.5 [1.2-17.2] days; p = 0.66). No differences were found in secondary clinical outcomes, including ventilator-free days (p = .25), hospital length of stay (p = .68), and mortality (p = .81). Ten (29%) patients in the haloperidol group reported symptoms consistent with akathisia, compared with six (20%) patients in the ziprasidone group and seven (19%) patients in the placebo group (p = .60), and a global measure of extrapyramidal symptoms was similar between treatment groups (p = .46). CONCLUSIONS: A randomized, placebo-controlled trial of antipsychotics for delirium in mechanically ventilated intensive care unit patients is feasible. Treatment with antipsychotics in this limited pilot trial did not improve the number of days alive without delirium or coma, nor did it increase adverse outcomes. Thus, a large trial is needed to determine whether use of antipsychotics for intensive care unit delirium is appropriate.