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HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

A randomised, double-blind, placebo controlled trial to compare the early administration of intravenous haloperidol versus placebo in the prevention and treatment of delirium in critically ill ventilated patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83567338
Enrollment
142
Registered
2011-01-21
Start date
2010-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Generic Health Relevance and Cross Cutting Themes

Interventions

Haloperidol 2.5 mg intravenously or 0.5 ml normal saline intravenously 8 hourly for up to 14 days or until the patient screens negative for delirium for 48 hours using the CAM-ICU. Follow up length:

Sponsors

West Hertfordshire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients requiring mechanical ventilation within 72 hours of admission 2. Male and female, aged 18 - 99 years

Exclusion criteria

Exclusion criteria: 1. Allergy to haloperidol 2. Chronic antipsychotic use 3. QTc greater than 500 msecs 4. History of torsades de pointes 5. Family history of dystonic reactions 6. Moribund and not expected to survive 7. Uncomplicated elective surgery 8. Expected to stay less than 48 hours 9. Moderate/severe dementia 10. Pregnancy 11. Parkinsons disease 12. Structural brain damage 13. History of neuroleptic malignant syndrome 14. Patients who do not understand English

Design outcomes

Primary

MeasureTime frame
Delirium/coma free days, measured at 14 days

Secondary

MeasureTime frame
1. Incidence of delirium 2. Delirium/coma free days in first 28 days 3. Number of ventilator free days at 28 days 4. Length of critical care and hospital stay 5. Mortality and cause of death at 6 months 6. Organ failure free days 7. Cognitive decline 8. Health related quality of life

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026