A Phase 4 interventional study of Haloperidol and Placebo Oral Tablet in Delirium, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by Zuyderland Medisch Centrum · Phase 4, Interventional, and Prevention
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 1,366 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Zuyderland Medisch Centrum is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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Exclusion criteria
Patients will receive oral haloperidol 2dd1mg (08.00am \& 10.00pm)
Drug: Haloperidol
Patients will receive oral placebo 2dd (08.00am \& 10.00pm)
Drug: Placebo Oral Tablet
Haloperidol 2dd1mg (08.00am - 10.00pm)
Also known as: Haldol, RVG 55776
Placebo oral 2dd (08.00am - 10.00pm)
Occurence of delirium
Will prophylactic haloperidol in high risk patients as established with DEMO reduce the incidence of delirium?
Time frame: Delirium within 5 days postoperative
Costs of treatment
Total costs of hospital stay
Time frame: up to 2 years
Days admitted to hospital
Total amount of days admitted to the hospital
Time frame: an average of two weeks
Adverse events of intervention medication
Adverse events during admission in the hospital
Time frame: an average of two weeks
Circulating concentration of Haloperidol
Blood sample collection at day, trough concentration haloperidol in blood sample
Time frame: up to 2 years
Duration of delirium
Days DOS (Delirium observation scale) positive after surgery,
Time frame: an average of two weeks
Severity of delirium
DOS scores during admission
Time frame: an average of two weeks
Plan to share: Undecided
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum