Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/01/2011
Date assigned
21/01/2011
Last edited
09/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Valerie J Page

ORCID ID

Contact details

60 Vicarage Road
Watford
WD18 0HB
United Kingdom
-
valerie.page@whht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9331

Study information

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

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase II

Drug names

Haloperidol

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

Overall trial start date

01/10/2010

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring mechanical ventilation within 72 hours of admission
2. Male and female, aged 18 - 99 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 142; UK sample size: 142

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

United Kingdom

Trial participating centre

60 Vicarage Road
Watford
WD18 0HB
United Kingdom

Sponsor information

Organisation

West Hertfordshire Hospitals NHS Trust (UK)

Sponsor details

60 Vicarage Road
Watford
WD18 0HB
United Kingdom
-
Fiona.smith@whht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.westhertshospitals.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24461612

Publication citations

Additional files

Editorial Notes