Immune Failure in Critical Therapy (INFECT) Study

University of Edinburgh

Status: Completed

Conditions: Septic Shock; Sepsis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02186522

2014/0208

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 1 patient group

Critical Care Patients

Description:

Patients staying in the ICU for at least 48 hours, requiring external support of one or more organs (invasive ventilation, inotropes/vasopressors or renal replacement therapy) and who are not expected to die within 48 hours of study entry.