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

Girard TD, Pandharipande PP, Carson SS, Schmidt GA, Wright PE, Canonico AE, Pun BT, Thompson JL, Shintani AK, Meltzer HY, Bernard GR, Dittus RS, Ely EW, MIND Trial Investigators
Crit Care Med. 2010 38 (2): 428-37

PMID: 20095068 · PMCID: PMC3645269 · DOI:10.1097/ccm.0b013e3181c58715

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.

MeSH Terms (18)

Adult Aged Antipsychotic Agents Delirium Double-Blind Method Female Haloperidol Humans Intensive Care Units Length of Stay Male Middle Aged Piperazines Postoperative Complications Psychiatric Status Rating Scales Respiration, Artificial Thiazoles Treatment Outcome

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