Early pharmacological intervention to prevent delirium: HAlopeRidol PrOphylaxis in Older emergency department patieNts. The HARPOON study
- Conditions
- acute state of confusiondelierDelirium10012221
- Registration Number
- NL-OMON39657
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 780
- Patients aged 70 years or over;
- The patient is at increased risk for developing in-hospital delirium on admission according to one or more positive answers on the VMS delirium-risk questions;
- The patient or proxy is able to provide written informed consent;
- The patient or proxy speaks either Dutch or English;
- The patient is admitted to the hospital for an internal or surgical specialty.
- Patients presenting in the ED with delirium according to the DSM-IV criteria;
- Patients with clinically significant (cardiac) disorders: QTc interval prolongation (QTc * 500ms), recent acute myocardial infarction, uncompensated heart failure (working diagnosis), acute coronary syndrome (ACS), arrhythmias treated with class IA and III antiarrhythmic medicinal products, history of ventricular arrhythmia, history of torsade de pointes, clinically significant bradycardia, second or third degree heart block, uncorrected hypokalaemia (potassium level 3.0 or lower);
- Patients with vascular dementia;
- Patients with Lewy Body dementia;
- Patients with Parkinson (dementia);
- Patients with (a history of) hypokinetic movement disorders;
- Patients with (a history of) malignant neuroleptic syndrome;
- Patients with (a history of) serotonergic syndrome;
- Patients with (a history of) central anticholinergic syndrome;
- Patients who will be admitted to the oncology ward;
- Patients who have been previously enrolled in the HARPOON study, or are currently enrolled in other medical- or drug (intervention) studies;
- Patients using co-medication of which concomitant use with haloperidol and/or during the 7-day intervention period according to protocol (SOP comedication) is contraindicated. Patients using QTc prolonging drugs at presentation with QTc *450ms (men) / QTc *460ms (women) on baseline ECG may be included in the study with repetitive ECG control according to protocol;
- Epilepsy
- Substance abuse and dependence (DSM-IV criteria)
- Patients who are not able to take study medication according to the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>An absolute reduction of delirium incidence of 10%.<br /><br>An absolute reduction of delirium duration (according to the DOS score,<br /><br>positive mean DOS score >3/24 uur indicated delirium).<br /><br>Less severe delirium in haloperidol intervention group (according to the<br /><br>gliding scale: DRS-R-98 score, >16 out of the total score of 39)</p><br>
- Secondary Outcome Measures
Name Time Method <p>A reduction of mean hospital length of stay.<br /><br>A reduction in 6-month mortality of 5%.</p><br>