The MIND Study: Modifying the INcidence of Delirium
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and
likely long-term brain deficits in survivors. This form of brain dysfunction occurs in
intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is
likely to worsen in upcoming years due to the aging of our population and increased
utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast
majority of circumstances in the ICU unless the patient presents with hyperactive delirium
and agitation. In the latter circumstance, a commonly used typical antipsychotic called
haloperidol is considered the principal agent for treating delirium based largely on
anecdotal evidence to support its usefulness, though no placebo controlled trials exist.
There are no FDA approved medications for delirium. The atypical antipsychotics provide a
promising alternative for the treatment of delirium due to their enhanced beneficial effects
on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia,
reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology,
and less potentially lethal heart rhythm disturbances. It is imperative that well-designed
phase II studies to determine proof of principle be conducted. A pilot study of feasibility
to begin assessing the role of antipsychotics in the management of ICU delirium.
Phase:
Phase 2
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center