Validation of Molecular and Protein Biomarkers in Sepsis

Summary

Background:

Sepsis (blood poisoning) is a clinical syndrome characterised by a dysregulated host response to infection causing life-threatening organ dysfunction which results in admission to an intensive care unit. It typically shows an initial harmful inflammation resulting from the immune system's overreaction to a severe infection. It is a major healthcare problem, affecting millions of people worldwide. In the UK, it kills over 37,000 people/year, costing the NHS £2.5 billion a year, and is increasing in incidence. Despite extensive efforts to tackle this burden, at present, however, there are no specific and effective therapies for this illness.

Sepsis is a potentially life-threatening condition caused by a severe infection. When someone develops sepsis, inflammation occurs not just at the site of the infection but throughout the whole body. This widespread inflammation can be very harmful. It is known that similar responses occur in other conditions, not relating to infection.

The investigators are recruiting patients with severe infections causing organ failure (also known as severe sepsis/ septicaemia and septic shock) and also patients where widespread inflammation, not related to infection, causes organ failure. In this study the investigators hope to find out whether certain groups of genetic and blood based protein markers of sepsis can forewarn the clinicians to this condition and also highlight patients who are responding well to the treatment.

Although it is known that the majority of the patients suffering from sepsis will survive their ICU stay and leave the hospital alive, there is insufficient data how these patients do on a longer term, i.e. after some time at home. To date there is little information on the ability of the observed genetic and blood based protein markers to predict the functional status of the patients surviving these conditions.

Conditions

• Sepsis
• Cardiac Arrest
• Pneumonia
• Abdominal Sepsis
• SIRS

Interventions

DIAGNOSTIC_TEST

mRNA expression

The primary objective is the external validation of our filed patent-claims panels of mRNA biomarkers, which in the inflammatory and SIRS/Sepsis panels have better discriminatory properties than any other published biomarker panel for detecting individuals with severe inflammation and differentiating infectious and non-infectious origin of organ failure (Sepsis/SIRS).

Sponsors & Collaborators

• Aneurin Bevan University Health Board

  collaborator OTHER

• Cardiff University

  collaborator OTHER

• Public Health England

  lead OTHER_GOV

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-25

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• United Kingdom

Study Locations