Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Septic shock, Critical care, Immune dysfunction, Inflammatory markers, Neutrophil, Monocyte, Tregs
Brief summary
Patients admitted to intensive care units (ICU) are at high risk of developing secondary infections, and this is in part due to dysfunction or failure of their 'germ killing' functions (the immune system). Our group has recently identified three signatures of immune system failure which can be readily detected on a blood sample, and importantly, appear to predict the chances of developing secondary infection. Such a test would have major benefits for the management of patients in intensive care if it can be translated into a test usable in everyday clinical practice. This study aims to validate our original findings in a cohort of patients from multiple ICUs, using a test which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test. Study hypothesis: Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict the risk of nosocomial infection.
Interventions
None listed
Sponsors
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
University of Edinburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>16 (\>18 in England) * Requiring level 3 care (i.e. requiring invasive support of respiratory system alone, or two or more other organ systems (haemofiltration, inotropes/vasopressors) * Predicted to remain in ICU for at least 48 hours,
Exclusion criteria
* Not expected to survive for a further 24 hours * Known or suspected ICU-acquired infection at time of screening (non-ICU acquired nosocomial infection - i.e. non-ICU healthcare associated infection is NOT and exclusion) * Known inborn errors of immune function * Immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose permitted) * HIV infection * Pregnancy * Previously enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period. | Within the first 16 days |
Secondary
| Measure | Time frame |
|---|---|
| Death from sepsis | Within first 16 days |
| Organ dysfunction as determined by SOFA score | Within first 14 days |
| Length of ICU stay | Up to 3 months (for current hospital admission only) |
| ICU Outcome (lived/died) | Within first 16 days |
| Duration of organ support in ICU | Within first 14 days |
Countries
United Kingdom
Outcome results
None listed