Immune Failure in Critical Therapy (INFECT) Study

NCT02186522 | Completed

• 1 other identifier: 2014/0208
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 4

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic shock; Critical care; Immune dysfunction; Inflammatory markers; Neutrophil; Monocyte; Tregs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ICU Outcome (lived/died)

  Within first 16 days

• 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)

• Duration of organ support in ICU

  Within first 14 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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,

You may not qualify if:

• Not expected to survive for a further 24 hours
• Known inborn errors of immune function
• Immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose permitted)
• HIV infection
• Pregnancy
• Previously enrolled in the study

Sponsors & Collaborators

• University of Edinburgh: lead
• Technology Strategy Board, United Kingdom: collaborator
• Becton, Dickinson and Company: collaborator

Study Sites (4)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29915941 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.

  PMID: 27431901 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of serum and plasma stored frozen

MeSH Terms

Conditions

Sepsis; Shock, Septic; Immune System Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2015-11

Locations

GB (4)