pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium

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.

Conditions

• Delirium

Interventions

DRUG

Haloperidol 1 mg/q8h

Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients: * aged ≥ 80 years * weight ≤ 50 kg * liver failure Patients with an adjusted dosage of study drug remain allocated to their original group. In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (\<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group.

DRUG

Haloperidol 2 mg/q8h

Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients: * aged ≥ 80 years * weight ≤ 50 kg * liver failure Patients with an adjusted dosage of study drug remain allocated to their original group. In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (\<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group.

DRUG

Placebo

Sodium Chloride 0.9%

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Mark van den Boogaard, PhD · Radboud University Nijmegen Medical Centre, Dept of Intensive Care Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-12-31

Completion

2017-03-31

Countries

• Netherlands

Study Locations