HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care; Injury, Occupational Diseases, Poisoning; Delirium in critically ill ventilated patients

• Registration Number: ISRCTN83567338
• Lead Sponsor: West Hertfordshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium/coma free days, measured at 14 days

Secondary Outcome Measures

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