An early treatment with haloperiodl to prevent acute confusion in older patients who are acutely admitted to the hospital.

• Conditions: Delirium; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-004762-15-NL
• Lead Sponsor: VU Univeristy Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-07
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 780

Exclusion Criteria

- 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 who are currently enrolled in other medical- or drug (intervention) studies;
- Patients using medications of which concomitant use with haloperidol and/or use 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 clinical trial of medicinal product
• Study Design: Not specified