Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trial

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 742

Inclusion Criteria

Inclusion criteria for eligibility:
1. Age >= 18 years
2. Admitted to one of six participating ICUs of the EuRIDICE trial.;Inclusion criteria for randomisation:
1. Delirium, as assessed with the Intensive Care Delirium Screening Checklist - ICDSC: >=4 or Confusion Assessment Method for the ICU - CAM-ICU: positive). NB Delirium can occur in the course of ICU admission or be present at admission.
2. Written Informed Consent is obtained from patient or legal representative
3. Complies with inclusion criteria but NOT exclusion criteria for eligibility (See above and exclusion criteria)

Exclusion Criteria

Exclusion criteria for eligibility:
1. Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
2. Pregnancy (to be excluded by pregnancy test in women of child baring age)
3. History of ventricular arrhythmia including *torsade de pointes* (TdP)
4. Known allergy to haloperidol
5. History of dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score >= 4
6. History of malignant neuroleptic syndrome or parkinsonism (either Parkinson*s disease or another hypokinetic rigid syndrome)
7. Schizophrenia
8. Inability to conduct valid delirium screening assessment (e.g. coma, deaf, blind) or inability to speak Dutch
9. The patient is expected to die within 24 hours, or is expected to leave the ICU within 24 hours after evaluation (may be reassessed daily);Exclusion criteria for randomisation:
1. Prolonged QT-interval (QTc > 500ms)
2. (recent) *torsade de pointes* (TdP)
3. (recent) malignant neuroleptic syndrome or parkinsonism
4. Evidence of acute alcohol (or substance) withdrawal requiring pharmacological intervention (e.g. benzodiazepines or alfa-2 agonist) to treat
5. IQCODE not assessed in patients >= 50 years old or with possible cognitive deterioration
6. The patient is expected to die within 24 hours.
7. No (previously) signed informed consent by patient or representative
8. Current participation in another intervention trial that is evaluating a medication, device or behavioural intervention

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Delirium- and coma free days at ICU [up to 14 days after randomisation].</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the efficacy of haloperidol to reduce ICU-delirium associated short-<br /><br>and long-term burdens (up to one-year), consisting of: 1) mortality; 2)<br /><br>cognitive and functional impairment; 3) patient- and family experiences and<br /><br>psychological sequelae during and after ICU stay; 4) safety concerns associated<br /><br>with haloperidol use.</p><br>