Haloperidol Prophylaxis in Older Emergency Department Patients

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose a multicenter, randomized, double-blinded, placebo-controlled trial to study the effect of additive low-dose haloperidol prophylaxis on top of exciting care in a general population of older patients (age 70 years and over) acutely admitted to the hospital through the emergency department (ED) for general medicine and surgical specialties, and who are at-risk for developing in-hospital delirium on admission according to the VMS delirium risk questions (one or more positive answers out of three questions).

The investigators hypothesize that this intervention will reduce the incidence of in-hospital delirium as well as duration and severity of delirium.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Antipsychotic Agents; Dopamine; Dopamine Antagonists; Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• Patients aged 70 years or over;

• The patient is at increased risk for developing in-hospital delirium on admission according to one or more positive answers on the VMS delirium-risk questions;

• The patient and/or proxy is able to provide written informed consent;

• The patient and/or proxy speaks either Dutch or English;

• The patient is admitted to the hospital for a general medicine or surgical specialty.

Exclusion Criteria:

• Patients presenting in the ED with delirium according to the DSM-IV criteria;

• Patients with clinically significant (cardiac) disorders: QTc interval prolongation (QTc ≥500ms), recent acute myocardial infarction, uncompensated heart failure (working diagnosis), acute coronary syndrome (ACS), arrhythmias treated with class IA and III antiarrhythmic medicinal products, history of ventricular arrhythmia, history of torsades, clinically significant bradycardia, second or third degree heart block, uncorrected hypokalaemia (potassium level 3.0 or lower);

• Patients with vascular dementia;

• Patients with Lewy Body dementia;

• Patients with Parkinson dementia;

• Patients with (a history of) hypokinetic movement disorders;

• Patients with (a history of) malignant neuroleptic syndrome;

• Patients with (a history of) serotonergic syndrome;

• Patients with (a history of) central anticholinergic syndrome;

• Patients who will be admitted to the oncology ward;

• Patients previously enrolled in the HARPOON study, or in other medical- or drug studies;

• Patients using QT prolonging drugs and/or medications of which concomitant use with haloperidol is contraindicated (clinically relevant drug interactions, 1st degree, listed in the appendix of the study protocol);

• Epilepsy;

• Substance abuse and dependence (DSM-IV criteria)

• Patients who are not able to take the study medication according to protocol (amendment)