Is haloperidol useful to prevent patients to develop a delier when they are at risk?

Phase 1

Conditions: Delirium
MedDRA version: 20.0Level: PTClassification code 10012218Term: DeliriumSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2017-001260-37-NL

Lead Sponsor: Zuyderland Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age > 60 years
•Planned elective surgery
•High-risk of developing delirium according to the DEMO model
•Absence of delirium pre-operatively

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 366
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

•Less than 1-day postoperative admission on ward
•Hypersensitivity to butyrophenone-derivatives
•Use of antipsychotics
•Not being able to take oral medication
•Presence of contraindications;
olesions of the basal ganglia,
oclinically significant heart disease,
oknown prolongation of the QT interval,
ohistory of ventricular arrhythmia and ‘torsades de pointes’,
ouncorrected hypokalemia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The hospital pharmacy at the Zuyderland Medical Centre developed the DElirium MOdel (DEMO) to predict which patients are at risk of developing a delirium in patients aged 60 or older. With this delirium risk prediction model we aim to predict more accurately which patients are at high risk of developing a delirium and want to investigate if these patients can benefit from prophylactic haloperidol. ;Secondary Objective: •Costs of treatment<br>•Days admitted to hospital<br>•Adverse events of intervention medication<br>•Circulating concentration of haloperidol<br>•Duration of delirium<br>•Severity of delirium (DOSS);Primary end point(s): Delirium incidence within five days after surgery;Timepoint(s) of evaluation of this end point: 5 days after admission

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Costs of treatment<br>•Days admitted to hospital<br>•Adverse events of intervention medication<br>•Circulating concentration of haloperidol<br>•Duration of delirium<br>•Severity of delirium (DOSS)<br>;Timepoint(s) of evaluation of this end point: 5 days after admission