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

PRODEO: PROfylactic Haloperidol in patients defined as high risk for DElirium with delirium risk mOdel - PRODEO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001260-37-NL

Enrollment

Unknown

Registered

2017-05-23

Start date

2017-05-23

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium MedDRA version: 20.0 Level: PT Classification code 10012218 Term: Delirium System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Haloperidol CF Product Name: haloperidol Product Code: 00005568 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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; o lesions of the basal ganglia, o clinically significant heart disease, o known prolongation of the QT interval, o history of ventricular arrhythmia and ‘torsades de pointes’, o uncorrected hypokalemia.

Design outcomes

Primary

Measure	Time frame
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 • Days admitted to hospital • Adverse events of intervention medication • Circulating concentration of haloperidol • Duration of delirium • 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	—

Measure

Time frame

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 • Days admitted to hospital • Adverse events of intervention medication • Circulating concentration of haloperidol • Duration of delirium • 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

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

Countries

Netherlands

Contacts

Public ContactDepartment of Clinical pharmacy

Zuyderland Medical Center

h.vanderkuy@zuyderland.nl+31884597709

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026