Delirium, delier
Conditions
Interventions
The intervention group will receive haloperidol, a butyrophenone-derived anti-psychotic with mainly dopamine-2 receptor antagonistic properties. Placebo consists of lactic acid and water for injection
Sponsors
Erasmus Medical Center, Rotterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for eligibility 1. Age ≥ 18 years 2. Admitted to ICU. 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
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 or other psychotic disorder 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 6. The patient is expected to die within 24 hours, or is expected to leave the ICU 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delirium- and coma free days at ICU (up to 14 days after randomisation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To study the efficacy of haloperidol to reduce ICU-delirium associated short- and long-term burdens (up to one-year), consisting of: 1) mortality; 2) cognitive and functional impairment; 3) patient- and family experiences and psychological sequelae during and after ICU stay. 2) Safety concerns associated with haloperidol use. | — |
Contacts
Public ContactMathieu Jagt, van der
Department of Intensive Care, room H-611, Erasmus MC
Outcome results
None listed