Respiratory Trials·org

Sedation, analgesia & delirium · Treating delirium

MIND-USA randomised trial

Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness

MIND-USA trial design and results
Design Phase 3, randomised, double-blind, placebo-controlled trial
Treatment Haloperidol, or ziprasidone
Control Placebo
Population 566 patients with acute respiratory failure or shock who developed delirium; 89% hypoactive and 11% hyperactive
Follow-up 90 days
Primary endpoint Number of days alive without delirium or coma during the 14-day intervention period
Result Neither haloperidol nor ziprasidone significantly altered the duration of delirium compared with placebo. Delirium developed in 566 of 1183 consented patients (48%).
Secondary endpoints Ventilator-free days, ICU and hospital length of stay, 30-day and 90-day mortality

The use of haloperidol or ziprasidone, as compared with placebo, in patients with acute respiratory failure or shock and hypoactive or hyperactive delirium in the ICU did not significantly alter the duration of delirium.

The trial authors, in the published abstract

How it has aged

Notable for what it reveals about the disease as much as the drug: 89% of the delirium was hypoactive, the form clinicians most often miss and least often think to sedate. Reinforced by AID-ICU four years later.

Publications

Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness

Girard TD, Exline MC, Carson SS, et al. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med 2018 Dec 27;379(26):2506-2516.

  • Neither haloperidol nor ziprasidone shortened delirium duration
  • 89% of delirium was hypoactive