HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial | Not Recruiting
HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial
HOPE-ICU trial
Trial Source

Health Conditions
  • Topic: Generic Health Relevance and Cross Cutting Themes
  • Subtopic: Generic Health Relevance (all Subtopics)
  • Disease: Critical Care
Not Recruiting
Recruitment Status
ISRCTN83567338
Primary Trial ID Number
Summary
This is a randomised placebo controlled, double blind, clinical effectiveness trial. It is designed to evaluate the effect of the early administration of haloperidol on duration of delirium in 142 mechanically ventilated patients at high risk of delirium. Delirium in intensive care patients is an independent risk factor for an increased in mortality and long term cognitive impairment. There is no definitive evidence to support the use of haloperidol to treat ICU delirium and the evidence of benefit and potential effects is conflicting. As of 08/02/2011 this record was updated to include new trial dates, as the previous ones are incorrect. The initial incorrect trial dates were as follows: Initial anticipated start date: 02/11/2010 Initial anticipated end date: 30/09/2012
Primary Outcome Measures
  • Delirium/coma free days, measured at 14 days
Secondary Outcome Measures
  • 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
Research Question
  • This is a randomised placebo controlled, double blind, clinical effectiveness trial. It is designed to evaluate the effect of the early administration of haloperidol on duration of delirium in 142 mechanically ventilated patients at high risk of delirium. Delirium in intensive care patients is an independent risk factor for an increased in mortality and long term cognitive impairment. There is no definitive evidence to support the use of haloperidol to treat ICU delirium and the evidence of benefit and potential effects is conflicting. As of 08/02/2011 this record was updated to include new trial dates, as the previous ones are incorrect. The initial incorrect trial dates were as follows: Initial anticipated start date: 02/11/2010 Initial anticipated end date: 30/09/2012
Design Type
Sorry, this information is not available
Ethics Approval
Berkshire Research Ethics Committee approved on the 7th September 2010 (ref: 10/H0505/65)
Publications
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24461612
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
142
Participant Inclusion Criteria
  • 1. Patients requiring mechanical ventilation within 72 hours of admission
  • 2. Male and female, aged 18 - 99 years
Participant 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
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: 6 months Study entry: single randomisation only
Design Details
Sorry, this information is not available
Study Design
Single centre randomised interventional placebo-controlled prevention and treatment phase II trial
Results Reporting
Sorry, this information is not available
Acronym
HOPE-ICU trial
Scientific Title
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
Secondary Trial Identifying Number
9331
Website
Sorry, this information is not available
Study Funded By
National Institute for Health Research
Funder Type
Sorry, this information is not available
Study Sponsored By
West Hertfordshire Hospitals NHS Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Oct 2010

Recruitment End Date

01 Jul 2013

Trial End Date

01 Jul 2013

Date added to Registry

21 Jan 2011

Last Updated

09 Jan 2015