Extract

Background and study aims Each year in the UK, about 31,000 people are admitted to critical care with severe sepsis, a syndrome where the body has an uncontrolled inflammatory response to infection which leads to damage to and subsequently failure of organs such as the lungs, heart and kidneys. Around one third of these patients die before discharge from hospital. Identifying these patients early and applying a strict protocol to control the amount of fluids, blood and drugs given may reduce the number of deaths and also the amount of time patients spend in hospital. However, we do not know whether this approach would be as successful if applied across all hospitals in the NHS. We aim to compare this protocol to the usual care delivered in NHS emergency departments and medical/surgical admissions units to establish the best approach to managing these patients. Who can participate? Patients aged 18 or over with the early signs of severe sepsis What does the study involve? Participants are randomly allocated either to be treated according to the new protocol or to receive the usual care. We assess the number of deaths within 90 days and the costs of each approach to determine whether the protocols offer good value for money to the NHS. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Intensive Care National Audit and Research Centre (ICNARC) (UK) When is the study starting and how long is it expected to run for? February 2011 to December 2013 Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK) Who is the main contact? Prof Kathryn Rowan [email protected]

Inclusion criteria

• Severe Sepsis, Septic Shock

Links

• isrctn
• ictrp