HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial
| ISRCTN | ISRCTN83567338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83567338 |
| Protocol serial number | 9331 |
| Sponsor | West Hertfordshire Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional placebo-controlled prevention and treatment phase II trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Haloperidol |
| Primary outcome measure(s) |
Delirium/coma free days, measured at 14 days |
| Key secondary outcome measure(s) |
1. Incidence of delirium |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 142 |
| Key inclusion criteria | 1. Patients requiring mechanical ventilation within 72 hours of admission 2. Male and female, aged 18 - 99 years |
| Key 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 |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
60 Vicarage Road
Watford
WD18 0HB
United Kingdom
WD18 0HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
