HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

• Research type

  Research Study

• Full 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

• IRAS ID

  42042

• Contact name

  Valerie J Page

• Sponsor organisation

  West Hertfordshire Hospitals NHS Trust

• Eudract number

  2009-017842-30

• ISRCTN Number

  83567338

• Research summary

  Does haloperidol prevent and/or treat delirium in critically ill ventilated patients?Many circumstances, e.g. severe infection or accident results in a person becoming critically ill. Patients with critical illness often develop impaired brain function - ??delirium?. This common condition affects up to 2 out of every 3 patients in Intensive Care Units (ICU), results in a longer ICU and hospital stay and a higher risk of death. Importantly, even after recovery from the initial illness, patients frequently experience impaired memory, a lower quality of life, e.g. many are unable to return to work or even look after themselves, essentially a mild or accelerated ??dementia?. There is no proven effective treatment for delirium. This study will investigate if the drug haloperidol, commonly used in the management of delirium, is safe and effective. Our study is a ??randomised placebo controlled trial?, widely accepted to be the best way to find out if a treatment really works or not. There will be 2 groups of 71 patients who will be given either haloperidol or a dummy drug (placebo). The group that a patient is in will be decided at random, the only difference between the 2 groups will be the treatment. We will count the number of days a patient has delirium, how fast they recover and how well their brain functions at 6 months using an approved telephone questionnaire. Haloperidol may reduce the time patients spend in ICU. Demand for ICU exceeds supply; a treatment that reduced use of ICU resources would result in increased capacity and improved access to appropriate facilities for critically ill patients. Furthermore delirium is associated with serious adverse outcomes; the potential impact of an effective treatment is considerable. This study is funded by a Research for Patients Benefit grant and run in partnership with the Alzheimer??s Society.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/65

• Date of REC Opinion

  7 Sep 2010

• REC opinion

  Further Information Favourable Opinion