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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• age ≥ 18

• expected length of ICU stay of over one day

Exclusion Criteria:

• history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, dementia or alcohol withdrawal syndrome

• patients admitted to the ICU for neurological reasons (including post-resuscitation patients)

• patients treated with other anti-psychotics

• prolonged QTc-time (>500msec) or history of serious ventricular arrhythmia (in last 12 months)

• pregnancy/breast feeding

• delirious before ICU admission

• serious auditory or visual disorders

• ICU-stay ≤1 day

• unable to understand Dutch

• severely mentally disabled

• serious receptive aphasia

• moribund and not expected to survive 2 days

• known allergy to haloperidol