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
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Haloperidol Drug: Placebo Oral Tablet||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||1366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Prophylactic Haloperidol arm
Patients will receive oral haloperidol 2dd1mg (08.00am & 10.00pm)
Haloperidol 2dd1mg (08.00am - 10.00pm)
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)
- 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?
- Costs of treatment [ Time Frame: up to 2 years ]Total costs of hospital stay
- Days admitted to hospital [ Time Frame: an average of two weeks ]Total amount of days admitted to the hospital
- Adverse events of intervention medication [ Time Frame: an average of two weeks ]Adverse events during admission in the hospital
- Circulating concentration of Haloperidol [ Time Frame: up to 2 years ]Blood sample collection at day, trough concentration haloperidol in blood sample
- Duration of delirium [ Time Frame: an average of two weeks ]Days DOS (Delirium observation scale) positive after surgery,
- Severity of delirium [ Time Frame: an average of two weeks ]DOS scores during admission
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
|Contact: Hugo van der Kuy||088 4595945 ext firstname.lastname@example.org|
|Zuyderland Medisch Centrum||Recruiting|
|Sittard, Limburg, Netherlands, 6162BG|
|Contact: Site sub-investigator 088-4595947 email@example.com|
|Sub-Investigator: Bauke Jansen, Bsc|
|Sub-Investigator: Rob Creemers, Bsc|
|Principal Investigator:||Hugo van der Kuy||Zuyderland MC|