Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis

Information for patients

Sepsis is the leading cause of admission to an intensive care unit in the UK, accounting for about 30% of all admissions.

1

Why do we need this study?

Overwhelming infection, often called sepsis, is a major problem for the health community. According to a recent report in the UK at least 100,000 people each year suffer from sepsis. Of these around 37,000 die – more than breast and bowel cancer combined. It is an illness that can affect people of any age and patients can become critically ill very quickly. The NHS spends at least £700 million per year treating these patients on intensive care units.

2

What happens in sepsis?

Frequently, sepsis leads to a fall in blood pressure that can lead to damage of other organs such as the kidney and liver. As more organs are damaged the risk of the patient dying increases. It is normal practice for intensive care doctors to attempt to restore a patient's blood pressure to a normal level using adrenaline-like drugs called catecholamines which can improve the functioning of the heart. However, it is increasingly being recognised that these drugs have important side effects and may even be associated with harm.

3

What is the purpose of this study?

This study is carefully designed to try and identify whether using a drug called levosimendan in patients with sepsis could produce important benefits by reducing multiple organ failure, which will then hopefully lead to better survival rates.

4

What's the treatment being investigated?

Levosimendan is a new type of drug that improves the function of the heart in a different manner to the adrenaline-like drugs. It has been extensively studied in patients with heart failure and is a licensed drug for this group of patients in many European countries and elsewhere around the world. In patients with sepsis around half may develop impaired heart function and associated kidney failure, and levosimendan has been shown to improve this. Its use in sepsis has been studied in both animals and man, and so far the small patient studies have shown promising results but none have been large enough to prove if it can help sepsis patients.

5

Which patients will be chosen to take part?

Patients being treated for sepsis on an intensive care unit and who have low blood pressure that requires the use of adrenaline-like drugs to maintain it will be asked to take part.

6

What does taking part in this study involve?

All patients will receive the normal care they would expect to receive. In order to work out whether levosimendan does actually work half will be randomly chosen to receive an additional infusion of levosimendan for 24 hours whilst the other half will receive a dummy treatment, or placebo. In some hospitals additional blood samples will be collected to allow us to try and work out how levosimendan might work in sepsis.