Effects of prophylactic use of haloperidol in critically ill patients with a high risk for delirium

Phase 4

Completed

Conditions: neuropsychiatric disorder
acute confusion
delirium

Registration Number: NL-OMON39725

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1789

Inclusion Criteria

All consecutive ICU patients:;- age >= 18 year;- expected length of ICU stay of over one day

Exclusion Criteria

- history of epilepsy, Parkinson*s disease, hypokinetic rigid syndrome, dementia or alcohol abuse
- patients admitted to the ICU for neurological reasons
- patients treated with other anti-psychotics
- prolonged QTc-time (over 500msec) or history of ventricular arrhythmia (in last 12 months)
- pregnancy
- delirious before ICU admission
- serious auditory or visual disorders
- ICU-stay <=1 day;- unable to understand Dutch
- severely mentally disabled
- serious receptive aphasia
- allergic to haloperidol
- moribund and not expected to survive 2 days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: To determine the effect of prophylactic haloperidol on<br /><br>28-day mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): There are five secondary outcome measures:<br /><br>1. To determine the effect of prophylactic haloperidol on 90-day mortality<br /><br>2. To determine the effect of prophylactic haloperidol on delirium incidence<br /><br>3. To determine the effect of prophylactic haloperidol on number of<br /><br>delirium-free and coma-free days in a period of 28 days<br /><br>4. To determine the effect of prophylactic haloperidol on delirium related<br /><br>outcome: duration of mechanical ventilation, incidence of re-intubation,<br /><br>incidence of ICU readmission, and incidence of unplanned removal of tubes and<br /><br>catheters<br /><br>5. To determine the preventive efficacy of haloperidol in different patient<br /><br>groups based on the a priori risk to develop delirium: patients with a<br /><br>predicted risk up to 50%, 50-70%, 70-90%, above 90%<br /><br>6. To evaluate side-effects of haloperidol treatment<br /><br>7. Effect on quality of life </p><br>