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van CCT (UK)

van CCT (UK)

Haloperidol prophylaxis in older emergency department patients.

- candidate number10700
- NTR NumberNTR3207
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2011
- Secondary IDsID474
- Public TitleHaloperidol prophylaxis in older emergency department patients.
- Scientific TitleEarly pharmacological intervention to prevent delirium: Haloperidol prophylaxis in older emergency department patients.
- hypothesisWe hypothesize that addition of low-dose haloperidol prophylaxis (1.0mg twice-daily) on top of the existing standard of care reduces in-hospital delirium incidence, severity and duration in a general patient population, age 70 years or over, who are acutely admitted to the hospital through the emergency department (ED) and who are at-risk for delirium on admission.
- Healt Condition(s) or Problem(s) studiedDelirium
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-nov-2012
- planned closingdate1-nov-2015
- Target number of participants600
- InterventionsEach 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 pm.
- Primary outcomeThe incidence (percentage, %) and duration (days) of in-hospital delirium in both study arms (haloperidol and placebo group).
- Secondary outcome1. 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.
- Timepoints1. Baseline;
2. 3 and 6 months after discharge.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryDelirium is a severe neuropsychiatric disorder occurring frequently in the acutely admitted, older patient. Hospital prevalence numbers range from 8.6% to 52% in patients aged 65 years or over. Older patients who develop delirium are at risk of developing a range of negative outcomes such as increased hospital length of stay (LOS), high morbidity and mortality, cognitive and functional decline and increased institutionalisation after hospital discharge. As a result of these (long-term) negative health outcomes, delirium is associated with increased (non-) healthcare costs. Due to expected increase in the elderly population, this will be an even more significant health-problem in the near future. What causes delirium is usually multi-factorial, which makes delirium management very difficult. In order to prevent delirium, intervention strategies targeting reversible risk factors have been developed. Implementing these measures reduces the incidence of delirium, but not the delirium severity and duration. There may to be a promising role for prophylactic use of a low dose (≤ 2.0mg/24 hours) of the typical antipsychotic drug haloperidol: currently the drug-of-choice in the treatment of delirium once it develops. In selected patients undergoing (elective) hip surgery, prophylactic treatment with low-dose haloperidol (1.5 ¨C 2.0mg/24 hours) in older at-risk patients seems to reduce severity and duration of delirium, though its effect on delirium incidence is non-significant. However, these results are hardly generalizable due to study population and study-size. Further research on the effectiveness of additive early haloperidol prophylaxis in the prevention of delirium in acutely admitted older patients is needed. Given its multifactorial origin and the fact that haloperidol is still the drug of choice in the symptomatic treatment of delirium, consistent with current guidelines though evidence is lacking, we propose a double-blind, randomized, placebo controlled trial to evaluate the efficacy of prophylactic low-dose haloperidol (1.0mg twice-daily), rather than antipsychotics, benzodiazepines or melatonin, on delirium prevention in an older at-risk general patient population. The risk of developing delirium during hospital admission will be determined according to criteria mentioned in the Dutch ˇ®Safety Management System (VMS) (
- Main changes (audit trail)
- RECORD16-dec-2011 - 8-sep-2014

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