PROfylactic Haloperidol in Patients Defined as High Risk for DElirium With Delirium Risk mOdel
PRODEO
Delirium: Is Prophylactic Drug Therapy Useful in High Risk Patients as Defined by the Delirium Risk Prediction Model?
2 other identifiers
interventional
1,366
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2017
CompletedStudy Start
First participant enrolled
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedJune 27, 2017
June 1, 2017
1.4 years
June 23, 2017
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of delirium
Will prophylactic haloperidol in high risk patients as established with DEMO reduce the incidence of delirium?
Delirium within 5 days postoperative
Secondary Outcomes (6)
Costs of treatment
up to 2 years
Days admitted to hospital
an average of two weeks
Adverse events of intervention medication
an average of two weeks
Circulating concentration of Haloperidol
up to 2 years
Duration of delirium
an average of two weeks
- +1 more secondary outcomes
Study Arms (2)
Prophylactic Haloperidol arm
EXPERIMENTALPatients will receive oral haloperidol 2dd1mg (08.00am \& 10.00pm)
No treatment
PLACEBO COMPARATORPatients will receive oral placebo 2dd (08.00am \& 10.00pm)
Interventions
Haloperidol 2dd1mg (08.00am - 10.00pm)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zuyderland Medisch Centrum
Sittard, Limburg, 6162BG, Netherlands
Related Publications (7)
Inouye SK, Studenski S, Tinetti ME, Kuchel GA. Geriatric syndromes: clinical, research, and policy implications of a core geriatric concept. J Am Geriatr Soc. 2007 May;55(5):780-91. doi: 10.1111/j.1532-5415.2007.01156.x.
PMID: 17493201BACKGROUNDDemeure MJ, Fain MJ. The elderly surgical patient and postoperative delirium. J Am Coll Surg. 2006 Nov;203(5):752-7. doi: 10.1016/j.jamcollsurg.2006.07.032. Epub 2006 Sep 26. No abstract available.
PMID: 17084339BACKGROUNDSalluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
PMID: 26041151BACKGROUNDLeslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.
PMID: 18195192BACKGROUNDFukata S, Kawabata Y, Fujisiro K, Katagawa Y, Kuroiwa K, Akiyama H, Terabe Y, Ando M, Kawamura T, Hattori H. Haloperidol prophylaxis does not prevent postoperative delirium in elderly patients: a randomized, open-label prospective trial. Surg Today. 2014 Dec;44(12):2305-13. doi: 10.1007/s00595-014-0859-7. Epub 2014 Feb 16.
PMID: 24532143BACKGROUNDWang W, Li HL, Wang DX, Zhu X, Li SL, Yao GQ, Chen KS, Gu XE, Zhu SN. Haloperidol prophylaxis decreases delirium incidence in elderly patients after noncardiac surgery: a randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):731-9. doi: 10.1097/CCM.0b013e3182376e4f.
PMID: 22067628BACKGROUNDde Wit HA, Winkens B, Mestres Gonzalvo C, Hurkens KP, Mulder WJ, Janknegt R, Verhey FR, van der Kuy PH, Schols JM. The development of an automated ward independent delirium risk prediction model. Int J Clin Pharm. 2016 Aug;38(4):915-23. doi: 10.1007/s11096-016-0312-7. Epub 2016 May 13.
PMID: 27177868BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo van der Kuy
Zuyderland MC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 23, 2017
First Posted
June 27, 2017
Study Start
June 23, 2017
Primary Completion
November 23, 2018
Study Completion
November 23, 2018
Last Updated
June 27, 2017
Record last verified: 2017-06