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| Name | Class |
|---|---|
| Technology Strategy Board, United Kingdom | OTHER |
| Becton, Dickinson and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical Care Patients | 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. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Outcome (lived/died) | Within first 16 days | |
| Death from sepsis | Within first 16 days | |
| Organ dysfunction as determined by SOFA score |
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Inclusion Criteria:
Exclusion Criteria:
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Critical Care patients who are expected to remain in ICU for at least 48 hours, and require the 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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Conway Morris, MD | University of Cambridge | Principal Investigator |
| Tim S Walsh, MD | NHS Lothian/University of Edinburgh | Principal Investigator |
| John Simpson, MD | Newcastle University | Principal Investigator |
| Alistair Roy, MD | City Hospitals Sunderland NHS Foundation Trust | Principal Investigator |
| Alun Brown | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Manu Shankar-Hari, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Anthony Bateman, MD | NHS Lothian (Western General Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom | |||
| Western General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29915941 | Derived | Conway Morris A, Datta D, Shankar-Hari M, Stephen J, Weir CJ, Rennie J, Antonelli J, Bateman A, Warner N, Judge K, Keenan J, Wang A, Burpee T, Brown KA, Lewis SM, Mare T, Roy AI, Hulme G, Dimmick I, Rossi AG, Simpson AJ, Walsh TS. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study. Intensive Care Med. 2018 May;44(5):627-635. doi: 10.1007/s00134-018-5247-0. Epub 2018 Jun 7. | |
| 27431901 |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Samples of serum and plasma stored frozen
| Within first 14 days |
| Length of ICU stay | Up to 3 months (for current hospital admission only) |
| Duration of organ support in ICU | Within first 14 days |
| Edinburgh |
| EH4 2XU |
| United Kingdom |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Sunderland Royal Hospital | Sunderland | SR4 7TP | United Kingdom |
| Derived |
| Conway Morris A, Datta D, Shankar-Hari M, Weir CJ, Rennie J, Antonelli J, Rossi AG, Warner N, Keenan J, Wang A, Brown KA, Lewis S, Mare T, Simpson AJ, Hulme G, Dimmick I, Walsh TS. Predictive value of cell-surface markers in infections in critically ill patients: protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study). BMJ Open. 2016 Jul 18;6(7):e011326. doi: 10.1136/bmjopen-2016-011326. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |