pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol
in patients with a high risk to develop delirium, defined by an expected ICU length of stay
of >1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a
high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.
Two different dosages of haloperidol are used in this study to compare with placebo. A dosage
of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a
three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the
potential beneficial effects of haloperidol to the a priori risk to develop delirium, the
PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable
the investigators to determine the preventive efficacy of haloperidol in patient groups based
on their risk to develop delirium.
Phase:
Phase 4
Details
Lead Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development