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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Topic: Generic Health Relevance and Cross Cutting Themes
  • Subtopic: Generic Health Relevance (all Subtopics)
  • Disease: Critical Care
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN83567338
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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
Phase
Phase II
Study Design
Single centre randomised interventional placebo-controlled prevention and treatment phase II trial
Study Type
Interventional
Intervention

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

Intervention Type
Drug
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
Publication(s)
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24461612
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned sample size: 142; UK 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
Trial Location(s)
Vicarage Rd
Watford
WD18 0HB
Trial Contact(s)
Primary Trial Contact
Dr Valerie J Page
valerie.page@whht.nhs.uk
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Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
9331
Sponsor(s)
West Hertfordshire Hospitals NHS Trust (UK)
Key Dates

Recruitment Start Date

01 Oct 2010

Recruitment End Date

01 Jul 2013

Trial Start Date

01 Oct 2010

Trial End Date

01 Jul 2013

Date Assigned

21 Jan 2011

Last Updated

09 Jan 2015