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

Recruiting

• Conditions: confusion; Delirium; 10012221

• Registration Number: NL-OMON45531
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1366

Inclusion Criteria

• Age > 60 years

• Planned elective surgery

• High-risk of developing delirium according to the DEMO model

• Absence of delirium pre-operatively

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>Delirium within maximal 5 days* admission </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study/endpoints<br /><br>• Confusion incidence at 5 days (described as verwardheid) Yes/No<br /><br>• Costs of treatment Euro<br /><br>• Days admitted to hospital Days<br /><br>• Adverse effects of intervention medication Yes/No<br /><br>• Amount of prescribed medications Numeric<br /><br>• Circulating concentration of haloperidol ng/ml</p><br>