Modifying Delirium Using Simvastatin - MoDUS

• Research type

  Research Study

• Full title

  Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in mechanically ventilated patients at high risk of delirium

• IRAS ID

  115539

• Contact name

  Valerie Page

• Sponsor organisation

  West Hertfordshire Hospitals NHS Trust

• Eudract number

  2012-003114-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Many different circumstances, e.g. severe infection or an accident may result in a person becoming critically ill. For reasons that are unclear, when people are critically ill, their brain function is often impaired - ??delirium?. Delirium is common affecting up to 2 out of every 3 patients in ICU, and results in a longer hospital stay and a higher risk of death. Importantly, after recovery from the initial illness, following delirium, patients frequently go on to experience the equivalent of a mild or accelerated ??dementia?. There is no proven effective treatment for delirium. It is thought that delirium is often a result of inflammation in the brain. Simvastatin, usually used to reduce cholesterol, has been shown to have significant anti-inflammatory properties. Our study is a ??randomised placebo controlled trial? which is widely accepted to be the best way to find out if a treatment really works. In this study there will be 2 groups of 71 patients randomly allocated to be given either simvastatin or a dummy drug (placebo). The only difference between the 2 groups will be the treatment. We will count the number of days a patient is delirious, how fast they recover and how well their brain functions at 6 months using an approved telephone questionnaire. If simvastatin reduces delirium it would likely decrease ICU stay. Demand for ICU exceeds supply and a treatment that reduced use of ICU resources would result in increased availability to appropriate facilities for critically ill patients. The results of this study would help decide whether a much larger and more expensive trial should be undertaken into the effect of simvastatin on brain function. The potential impact of an effective treatment for delirium is considerable. Dr Valerie Page is currently leading a team running a similar study at Watford General Hospital ICU. This study is being funded by a Research for Patients Benefit Grant and run in partnership with ICUSteps and the Alzheimer's Society.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0383

• Date of REC Opinion

  6 Dec 2012

• REC opinion

  Further Information Favourable Opinion