ISRCTN 92093279, EudraCT number: 2005-003438-17
More recently it has been found to have widespread anti-inflammatory and immuno-modulatory properties. As a consequence, it has been suggested that simvastatin may have a role in the treatment of sepsis. This argument is supported by data from animal models and case-control studies in humans.
This study will be the first double-blind, randomised, controlled trial of simvastatin (40mg) versus placebo in the treatment of severe sepsis in humans. It will investigate the effect of simvastatin on important inflammatory markers and monitor the safety and feasibility of administering simvastatin to patients with severe sepsis. If simvastatin has a significant effect on the inflammatory cascade in vivo there will be a sound biological rationale for proceeding with a large, multi-centre trial of simvastatin in severe sepsis.
Patients that are admitted to the Adult Intensive Care Unit at the John Radcliffe Hospital, Oxford and the Adult Intensive Care Units of the Brighton and Sussex University Hospitals NHS Trust and with suspected severe sepsis will be approached to enter the study.
This project has been funded by the Moulton Charitable Trust.
The sponsor of this trial is the Oxford Radcliffe Hospitals NHS Trust.
Dr V S Barber
Kadoorie Centre for Critical Care Research and Education
The John Radcliffe Hospital
Headington OXFORD OX3 9DU
Tel: 01865 857626
Fax: 01865 857611
In emergencies: 07900 580999
Randomisation service provided by: Sealed Envelope.com