Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal
delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium
refers to a temporary change in the way a person thinks about things. Delirium occurs in
patients admitted to the hospital particularly those patients that are very sick, who are
given a number of medications, and who are not able to sleep normally. It affects their
behavior, their understanding of the people and things around them, and their ability to make
decisions. While ICU doctors do everything possible to eliminate the factors that may cause
delirium, delirium may cause a person to become very agitated which if not controlled is
dangerous to their safety as well as the safety of those around them. As well, if delirium
develops in patients in the ICU, it may increase the risk for death, keep patients in both
the ICU and hospital for longer and send patients to a long term care facility rather than
home after they are discharged from the hospital. A recent medical report found that patients
in the ICU who develop subsyndromal delirium have a mortality rate, a length of stay in both
the ICU and the hospital, and a transfer rate to a long term care facility that is nearly as
great as patients with delirium and greater than patients who develop neither subsyndromal
delirium or delirium. Recent studies in non-ICU patients suggest that if a patient who is at
high risk for developing delirium receives a medication called an antipsychotic (e.g.
haloperidol) they may not be as likely to develop delirium or if they do develop delirium it
will not last as long. No studies have evaluated the effect of administering an antipsychotic
in patients in the ICU who have subsyndromal delirium. Another study completed in the ICUs at
Tufts Medical Center found that there may be an association between the development of
delirium in patients with subsyndromal delirium and the use of haloperidol. However, this
small study had many limitations and thus it is not currently known whether using haloperidol
in patients with subsyndromal delirium will actually cause fewer of these patients to develop
delirium. Haloperidol makes a person sleepy and helps control behavior like agitation.
Haloperidol is the drug that is used most often to help control delirium in the ICU. This
prospective, double-blind, randomized controlled study will determine if haloperidol
administered through the vein four times daily (1mg IV q6h) to patients who have subsyndromal
delirium, and who are on a breathing machine and being cared for by the Medical ICU service
at Tufts Medical Center, will help prevent patients from developing delirium. A total of 68
participants will be enrolled. Exclusion criteria are extensive and include conditions that
could affect the ability to determine if delirium is present or increase the risk for side
effects related to the administration of haloperidol. Patients older than 80 will be excluded
from the study. Study medication (i.e. haloperidol) will be administered until one the
following occurs: 1) delirium develops (that is confirmed by a staff psychiatrist or his
designate, 2) the patient is discharged from the ICU at Tufts Medical Center, 3) the patient
has received haloperidol or placebo for 10 days or 4) an adverse event potentially
attributable to the study drug is experienced by a patient that is deemed, in the opinion of
a pulmonologist member of the investigative team to warrant discontinuation of therapy.
Haloperidol may cause unwanted side effects such as low blood pressure, twitching, and an
unsafe abnormal heart rhythm. Patients with chronic confusion (e.g., a dementia such as
Alzheimer's Disease) should not receive haloperidol and will not be included in this study.
Patients will be carefully monitored for side effects that are potentially related to
haloperidol. Patients who become confusion-free in the ICU before they leave the ICU (i.e.,
have no subsyndromal delirium) will be asked to provide consent for all research activities
that occured in the ICU. If patients where cognition is regained (ie. no subsyndromal
delirium or delirium) are not willing to provide consent then any study data collected from
them while they were in the ICU will be destroyed and they will not be approached to
participate in the post-ICU component of the study. This study also seeks to understand how
the use of haloperidol in the ICU in patients with subsyndromal delirium may have affect
memory, emotional status, happiness, ability to function, and quality of sleep in patients
after they leave the ICU. Patients (that do not have delirium based on CAM screening at the
time the 3-10 day and 6 month assessments are attempted) will be approached to participate in
this post-ICU component of the study.