Haloperidol for Delirium in Adult Critically Ill Patients

• Status: Active, not recruiting
• Trial end date: 2021-02-04
• Target enrollment: 0
• Participant gender: All

Summary

The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Further, patient and family experiences and cost-effectiveness will be assessed. Finally, safety concerns associated with the use of haloperidol in this vulnerable population will be studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

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:

Eligibility

Inclusion criteria for eligibility

1. Age ≥ 18 years

2. Admitted to ICU.

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