Delirium
Conditions
Interventions
Each subject will be randomly assigned to prophylactic treatment with either haloperidol or placebo for 7 days, starting the day of hospital admission. Dosage schedule: 1 mg twice-daily at 12am and 8
Sponsors
VU Univeristy Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients age 70 years or over; 2. First presentation in the ED in the last month; 3 The patient and/or proxy is able to provide informed consent; 4 The patients and/or proxy speaks either Dutch or English; 5 The patient is at-risk for delirium according to the Dutch VMS delirium risk-questions; 6 The patient is admitted to the acute admission facility (AOA), general internal medicine (including geriatric unit) or surgery/orthopaedics department.
Exclusion criteria
Exclusion criteria: 1. Patients presenting in the ED with delirium according to the DSM-IV criteria; 2. Patients with clinically significant cardiac disorders: A. QTc interval prolongation (QTc ≥ 500ms); B. Recent acute myocardial infarction; C. Uncompensated heart failure; D. Acute coronary syndrome (ACS); E. Arrhythmias treated with class IA and III antiarrhythmic medicinal products; F. History of ventricular arrhythmia; G. History of torsades de pointes; H. Clinically significant bradycardia; I. Second or third degree heart block; J. Uncorrected hypokalaemia. 3. Patients with vascular dementia; 4. Patients with Lewy Body dementia; 5. Patients with Parkinson dementia; 6. Patients with (a history of) hypokinetic movement disorders; 7. Patients with (a history of) malignant neuroleptic syndrome; 8. Patients with (a history of) serotonergic syndrome; 9. Patients with (a history of) central anticholinergic syndrome; 10. Patients who will be admitted to the oncology ward; 11. Patients who are enrolled in other medical- or drug studies; 12. Patients using QT prolonging drugs and other drugs of which concomitant use with haloperidol is contraindicated; 13. Patients using antipsychotics; 14. Patients using intramuscular neuroleptic depot injections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence (percentage, %) and duration (days) of in-hospital delirium in both study arms (haloperidol and placebo group). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of delirium free days (days), which if in-hospital delirium develops, is defined by the number of days from hospital admission to the day delirium is diagnosed according to the DSM-IV; 2. Mean hospital length-of-stay (days); 3. Mortality (in-hospital, or during follow-up 3 or 6 months after hospital discharge); 4. (I)ADL function; 5. (Long-term) institutionalization (%); 6. Cost effectiveness. | — |
Contacts
Public ContactP.W.B. Nanayakkara
VUmc De Boelelaan 1117
Outcome results
None listed