HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

Recruiting

• Source

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  Public Title	HalOPeridol Effectiveness in ICU delirium - the 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
  Acronym	HOPE-ICU trial
  Primary Trial Identifying Number	ISRCTN83567338
  Secondary Identifying Number	9331
  Source of Record	Data provided by the ISRCTN Register http://isrctn.org
  Source of Record URL	http://isrctn.org/ISRCTN83567338
  Date of Registration	2011-01-21
  Date Last Updated	2011-02-08
  Date Record Refreshed on UKCTG	2013-04-16

• Trial

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  Research Question	Sorry, not currently available
  Ethics Approval	Berkshire Research Ethics Committee approved on the 7th September 2010 (ref: 10/H0505/65)
  Study Design	Single centre randomised interventional placebo-controlled prevention and treatment phase II trial
  Design Type	Sorry, not currently available
  Design Details	Sorry, not currently available
  Health Condition(s) or Problem	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care
  Participants Inclusion Criteria	1. Patients requiring mechanical ventilation within 72 hours of admission 2. Male and female, aged 18 - 99 years
  Participants 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
  Participant Sex	Sorry, not currently available
  Participant Age Range	Sorry, not currently available
  Participant Type	Sorry, not currently available
  Target Sample Size	Planned sample size: 142; UK sample size: 142
  Date of First Enrolment	Sorry, not currently available
  Date of Recruitment End	Sorry, not currently available
  Date of End of Follow-up	Sorry, not currently available
  Trial End Date	Sorry, not currently available
  Recruitment Status	Recruiting
  Overall Trial Status	Sorry, not currently available
  Countries of Recruitment	United Kingdom
  Nation	England
  Location	Watford
  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
  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
  Website	Sorry, not currently available

• Results

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  Results Reporting	Sorry, not currently available
  Publications	Sorry, not currently available

• Contact

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  Contact for Public Queries	Dr Valerie J Page 60 Vicarage Road Watford WD18 0HB United Kingdom valerie.page@whht.nhs.uk
  Contact for Scientific Queries	Sorry, not currently available

• Sponsor

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  Study sponsored by	West Hertfordshire Hospitals NHS Trust (UK) 60 Vicarage Road Watford WD18 0HB United Kingdom Fiona.smith@whht.nhs.uk http://www.westhertshospitals.nhs.uk
  Study also sponsored by	Sorry, not currently available
  Primary Sponsor Type	Sorry, not currently available
  Secondary Sponsor Type	Sorry, not currently available

• Funder

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  Study funded by	National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
  Funder Type	Sorry, not currently available