HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial
| ISRCTN | ISRCTN83567338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83567338 |
| Secondary identifying numbers | 9331 |
- Submission date
- 21/01/2011
- Registration date
- 21/01/2011
- Last edited
- 09/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Valerie J Page
Scientific
Scientific
60 Vicarage Road
Watford
WD18 0HB
United Kingdom
| valerie.page@whht.nhs.uk |
Study information
| Study design | Single centre randomised interventional placebo-controlled prevention and treatment phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | HOPE-ICU trial |
| Study hypothesis | 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 |
| Ethics approval(s) | Berkshire Research Ethics Committee approved on the 7th September 2010 (ref: 10/H0505/65) |
| Condition | Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Haloperidol |
| Primary outcome measure | 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 |
| Overall study start date | 01/10/2010 |
| Overall study end date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target 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 |
| Recruitment start date | 01/10/2010 |
| Recruitment end date | 01/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
60 Vicarage Road
Watford
WD18 0HB
United Kingdom
WD18 0HB
United Kingdom
Sponsor information
West Hertfordshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
60 Vicarage Road
Watford
WD18 0HB
England
United Kingdom
| Fiona.smith@whht.nhs.uk | |
| Website | http://www.westhertshospitals.nhs.uk |
"ROR" |
https://ror.org/03e4g1593 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
