Simvastatin in ALI (HARP 2)

• Research type

  Research Study

• Full title

  Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP 2)

• IRAS ID

  55397

• Contact name

  Daniel Francis McAuley

• Sponsor organisation

  BHSCT

• Eudract number

  2010-020763-20

• ISRCTN Number

  ISRCTN88244364

• Research summary

  A Study to Determine Whether Simvastatin Is Of Therapeutic Value In Patients With Acute Lung Injury (ALI).When people are critically ill their lungs often fail, this is termed "acute lung injury". As a result, a person's breathing becomes difficult and a "ventilator", a machine to assist breathing, is needed to take over their breathing. The aim of this study is to investigate if simvastatin, a drug commonly used to treat high cholesterol, is safe and effective in the treatment of ALI.Demand for ICU care exceeds supply and a treatment which reduces the use of ICU resources would result in increased capacity and improved access to appropriate facilities for critically ill patients. The study is open to patients aged 16 and over who are admitted to specified ICU wards in the UK who are suffering from ALI. In this study, there will be two groups of people; one group will be given simvastatin and the other group a dummy drug (placebo) for up to 28 days. The group (and thus the specific treatment) that a person is allocated to, is decided 'at random' using a computer programme. This ensures that the two groups of patients are the same in all ways except for that treatment. We will determine how long patients need assistance with their breathing on a ventilator and how fast they recover. We will also take blood and urine samples to determine the ways by which lung injury develops and by which simvastatin might work to alleviate the condition. Patients will be contacted at 3, 6 and 12 months after discharge to fill in a questionnaire to measure the residual effects of the illness on their lives.This study is funded by the National Institute of Health Research, Efficacy and Mechanism Evaluation Programme.

• REC name

  HSC REC B

• REC reference

  10/NIR02/36

• Date of REC Opinion

  8 Sep 2010

• REC opinion

  Further Information Favourable Opinion