Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: The MIND randomized, placebo-controlled trial

Timothy D GIRARD; Pratik P PANDHARIPANDE; Gordon R BERNARD; Robert S DITTUS; E. Wesley Ely; Shannon S CARSON; Gregory A SCHMIDT; Patrick E WRIGHT; Angelo E CANONICO; Brenda T PUN; Jennifer L THOMPSON; Ayumi K SHINTANI; Herbert Y MELTZER; MIND Trial Investigators

doi:10.1097/CCM.0b013e3181c58715

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Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: The MIND randomized, placebo-controlled trial

Journal article

Peer reviewed

Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: The MIND randomized, placebo-controlled trial

Timothy D GIRARD, Pratik P PANDHARIPANDE, Gordon R BERNARD, Robert S DITTUS, E. Wesley Ely, Shannon S CARSON, Gregory A SCHMIDT, Patrick E WRIGHT, Angelo E CANONICO, Brenda T PUN, …

Critical care medicine, Vol.38(2), pp.428-437

2010

DOI: 10.1097/CCM.0b013e3181c58715

PMID: 20095068

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https://www.ncbi.nlm.nih.gov/pmc/articles/3645269View

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Abstract

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.

Biological and medical sciences

Intensive care medicine

Clinical death. Palliative care. Organ gift and preservation

Medical sciences

Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy

Details

Title: Subtitle: Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: The MIND randomized, placebo-controlled trial
Creators: Timothy D GIRARD - Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, United States
Pratik P PANDHARIPANDE - Center for Health Services Research, Vanderbilt University School of Medicine, Nashville, TN, United States
Gordon R BERNARD - Anesthesia Service, Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, TN, United States
Robert S DITTUS - Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, United States
E. Wesley Ely - Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, United States
Shannon S CARSON - Department of Anesthesiology, Division of Critical Care, Vanderbilt University School of Medicine, Nashville, TN, United States
Gregory A SCHMIDT - Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, United States
Patrick E WRIGHT - Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, TN, United States
Angelo E CANONICO - Department of Medicine, Division of Pulmonary and Critical Care Medicine (SSC), University of North Carolina, Chapel Hill, NC, United States
Brenda T PUN - Department of Internal Medicine, Division of Pulmonary Diseases, Critical Care, and Occupational Medicine (GAS), University of Iowa Carver College of Medicine, Iowa City, IA, United States
Jennifer L THOMPSON - Moses H. Cone Memorial Hospital, Greensboro, NC, United States
Ayumi K SHINTANI - Department of Medicine (AEC), Saint Thomas Hospital, Nashville, TN, United States
Herbert Y MELTZER - Geriatric Research, Education, and Clinical Center Service, Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, TN, United States
MIND Trial Investigators
Resource Type: Journal article
Publication Details: Critical care medicine, Vol.38(2), pp.428-437
DOI: 10.1097/CCM.0b013e3181c58715
PMID: 20095068
NLM abbreviation: Crit Care Med
ISSN: 0090-3493
eISSN: 1530-0293
Publisher: Lippincott Williams & Wilkins
Language: English
Date published: 2010
Academic Unit: Pulmonary, Critical Care, and Occupational Medicine; Internal Medicine
Record Identifier: 9984094497502771

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