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

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ClinicalTrials.gov Identifier: NCT03199950
Recruitment Status : Unknown
Verified June 2017 by Hugo Van der Kuy, Zuyderland Medisch Centrum.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hugo Van der Kuy, Zuyderland Medisch Centrum

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Haloperidol Drug: Placebo Oral Tablet Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Delirium: Is Prophylactic Drug Therapy Useful in High Risk Patients as Defined by the Delirium Risk Prediction Model?
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : November 23, 2018
Estimated Study Completion Date : November 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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)




Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. Costs of treatment [ Time Frame: up to 2 years ]
    Total costs of hospital stay

  2. Days admitted to hospital [ Time Frame: an average of two weeks ]
    Total amount of days admitted to the hospital

  3. Adverse events of intervention medication [ Time Frame: an average of two weeks ]
    Adverse events during admission in the hospital

  4. Circulating concentration of Haloperidol [ Time Frame: up to 2 years ]
    Blood sample collection at day, trough concentration haloperidol in blood sample

  5. Duration of delirium [ Time Frame: an average of two weeks ]
    Days DOS (Delirium observation scale) positive after surgery,

  6. Severity of delirium [ Time Frame: an average of two weeks ]
    DOS scores during admission



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199950


Contacts
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Contact: Hugo van der Kuy 088 4595945 ext 0031 h.vanderkuy@zuyderland.nl

Locations
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Netherlands
Zuyderland Medisch Centrum Recruiting
Sittard, Limburg, Netherlands, 6162BG
Contact: Site sub-investigator    088-4595947    prodeo@zuyderland.nl   
Sub-Investigator: Bauke Jansen, Bsc         
Sub-Investigator: Rob Creemers, Bsc         
Sponsors and Collaborators
Zuyderland Medisch Centrum
Investigators
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Principal Investigator: Hugo van der Kuy Zuyderland MC

Publications:

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Responsible Party: Hugo Van der Kuy, Principle Investigator, Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT03199950     History of Changes
Other Study ID Numbers: 17-T-31
2017-001260-37 ( EudraCT Number )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Van der Kuy, Zuyderland Medisch Centrum:
Delirium
Haloperidol
Prophylactic
High-risk
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents