PROfylactic Haloperidol in Patients Defined as High Risk for DElirium With Delirium Risk mOdel (PRODEO)

June 26, 2017 updated by: Hugo Van der Kuy, Zuyderland Medisch Centrum

Delirium: Is Prophylactic Drug Therapy Useful in High Risk Patients as Defined by the Delirium Risk Prediction Model?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intro: Delirium is a common postoperative complication within geriatric patients. It is described delirium as a very stressful experience for the patient which can lead to prolonged hospital stay, higher cost, additional morbidity and increased mortality.

In 2013 the hospital pharmacy at the Zuyderland Medical Center developed the delirium risk prediction model to determine the chance of development of a delirium in patients aged 60 or older. Electronically available data such as age, polypharmacy, use of anti-dementia drugs, anti-depressants, anti-parkinsonian drugs, anti-diabetics, analgesics and/or sleeping medication were used in the study. The delirium risk prediction model was validated prospectively after retrospective development. The model will be used in this study to predict the risk of developing delirium postoperatively.

We expect prophylactic haloperidol to be effective in patients with a high risk of developing a delirium according to the delirium risk prediction model.

Aim: The PRODEO-study aims to reduce the incidence of postoperative delirium by administering prophylactic haloperidol to patients with a high risk of developing delirium according to the delirium risk prediction model.

Methods: The study is a randomized and double blind single center study with two parallel groups. Subjects ≥60 years with increased risk of postoperative delirium according to the delirium risk prediction model undergoing elective chirurgical or elective orthopedic surgery are eligible. Subjects will be excluded if they already use anti-psychotic drugs, are not able to take oral medication or when there are contra-indications. Haloperidol (1mg) or placebo will be administered at set times postoperatively. Subjects receive haloperidol 2dd1mg or a placebo 2dd during a maximum of five days during admission. On day 3 blood samples will be obtained in order to determine the true concentration levels of haloperidol. The primary endpoint is delirium incidence within 5 days after surgery. Secondary endpoints are costs of treatment, number of admission days, adverse events, true concentration levels of haloperidol and duration and severity of delirium.

Results: The study will start in June 2017 with an inclusion rate of 20 patients per week. An incidence reduction of 30% in the intervention group is expected. To reach sufficient statistical power a study population of 1366 subjects is needed. Duration of the inclusion period is expected to be 18 months.

Study Type

Interventional

Enrollment (Anticipated)

1366

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Limburg
      • Sittard, Limburg, Netherlands, 6162BG
        • Recruiting
        • Zuyderland Medisch Centrum
        • Contact:
        • Sub-Investigator:
          • Bauke Jansen, Bsc
        • Sub-Investigator:
          • Rob Creemers, Bsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Age >60 years
  • Planned elective surgery
  • General surgery or orthopaedic surgery
  • At least one night postsurgical admission
  • High-risk developing delirium according to the DEMO-model
  • Absence of delirium pre-operatively

Exclusion criteria

  • Less than 1-day postoperative admission in hospital
  • Hypersensitivity to butyrophenone derivates
  • Use of antipsychotics
  • Not being able to take oral medication
  • Presence of contraindications (lesions of basal ganglia, clinical significant heart disease (eg. recent acute myocardial infarction, non-compensated heart failure, arrythmias treated with drugs out of the NYHA(New York Heart Association)-class Ia and II anti-arrythmics), known prolongation of the QT interval, history of ventricular arrythmia and torsades de pointes, uncorrected hypokalemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylactic Haloperidol arm
Patients will receive oral haloperidol 2dd1mg (08.00am & 10.00pm)
Drug: Haloperidol
Haloperidol 2dd1mg (08.00am - 10.00pm)
Other Names:
  • Haldol
  • RVG 55776
Placebo Comparator: No treatment
Patients will receive oral placebo 2dd (08.00am & 10.00pm)
Drug: Placebo Oral Tablet
Placebo oral 2dd (08.00am - 10.00pm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of delirium
Time Frame: Delirium within 5 days postoperative
Will prophylactic haloperidol in high risk patients as established with DEMO reduce the incidence of delirium?
Delirium within 5 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs of treatment
Time Frame: up to 2 years
Total costs of hospital stay
up to 2 years
Days admitted to hospital
Time Frame: an average of two weeks
Total amount of days admitted to the hospital
an average of two weeks
Adverse events of intervention medication
Time Frame: an average of two weeks
Adverse events during admission in the hospital
an average of two weeks
Circulating concentration of Haloperidol
Time Frame: up to 2 years
Blood sample collection at day, trough concentration haloperidol in blood sample
up to 2 years
Duration of delirium
Time Frame: an average of two weeks
Days DOS (Delirium observation scale) positive after surgery,
an average of two weeks
Severity of delirium
Time Frame: an average of two weeks
DOS scores during admission
an average of two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Hugo van der Kuy, Zuyderland MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2017

Primary Completion (Anticipated)

November 23, 2018

Study Completion (Anticipated)

November 23, 2018

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-T-31
  • 2017-001260-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delirium

Clinical Trials on Haloperidol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe