MedTrace Logo

Haloperidol Prophylaxis in Older Emergency Department Patients

NCT01530308 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2015-11-26

No results posted yet for this study

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.

Conditions

  • Delirium

Interventions

DRUG

Haloperidol

An oral dosage of 1mg twice daily at 12am and 8pm.

DRUG

Placebo

An oral dosage of 1mg twice-daily at 12am and 8 pm.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • P WB Nanayakkara, Md, PhD · Amsterdam UMC, location VUmc

  • O J de Vries, MD · Amsterdam UMC, location VUmc

  • P M Bet, Pharm D · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-04-30
Completion
2015-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530308 on ClinicalTrials.gov