Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study

Sepsis Clinical Trial

— ExPRES  

Official title:

Early Prediction of Severe Sepsis (ExPRESSepsis) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188992
• Other study ID #: 2013/0267
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: October 25, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: July 2014
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Between 6 and 16% of patients presenting to hospital emergency departments have infections, with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue is that, at time of presentation, it can be difficult to determine who has inflammation as a result of infection and who does not.

Some of the patients with infections will deteriorate to organ failure ('severe sepsis') including failure of the heart and blood vessels to maintain normal blood pressure ('septic shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with a significant mortality, which can be reduced by early intervention. However identifying those patients who are at high risk of deteriorating to septic shock can be difficult on initial presentation to hospital, and thus these patients risk being 'triaged' to an inappropriate level of care and/or missing the crucial early interventions which can modify mortality. Equally failure to identify which patients have underlying infections can lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are often unable to accurately identify those patients with infection, and those who are likely to deteriorate to severe sepsis and septic shock.

Investigators in this group have recently identified several signatures of immune system activation which predict those patients who are likely to deteriorate, and which patients with suspected infection subsequently have this confirmed. Such tests would have major benefits for the management of patients with early suspected infection and sepsis if they can be translated into a test usable in everyday clinical practice. This study aims to determine the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and their predictive ability for developing established septic shock. From this investigators aim to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test.

Study hypothesis is:

Measurement of markers of immune activation will allow i) Risk stratification for deterioration into severe sepsis ii) Risk stratification for death amongst patients presenting with sepsis iii) Identification of patients with confirmed sepsis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age >16 (>18 in England)

• SIRS criteria met (2 or more of White Cell Count (WCC) >11 or <4, Heart Rate (HR) >90, Respiratory Rate (RR) >20 or temp >38 or <36oC)

• Clinical suspicion of sepsis (cultures taken or antibiotics started)

• Enrolled within 12 hours of hospital admission

Exclusion Criteria:

• Acute pancreatitis

• Septic shock at time of enrolment

• Severe organ failure at time of enrolment (immediate requirement for ventilation, vasopressor or renal replacement therapy)

• Haematological malignancy

• Recent chemotherapy (past 2 weeks)

• Myelodysplastic syndromes

• Known neutropaenia

• HIV infection

• Pregnancy

• Blood transfusion >4 units in past week

• Oral Corticosteroids for >24 hours prior to enrolment

• Decision not for active therapy/ palliative care at admission

• Lacking in capacity to consent and nearest relative/welfare guardian not available for consultation and proxy consent (Scotland only)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	St Thomas' Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Becton, Dickinson and Company, Technology Strategy Board, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of septic shock		Within first 72 hours	No
Primary	Confirmation of suspected infection		within first 72 hours	No
Secondary	Hospital outcome (lived/died)		Within first 72 hours	No
Secondary	Time to septic shock onset		Within the first 72 hours	No
Secondary	Death from sepsis		Within first 72 hours	No
Secondary	Organ dysfunction, total and individual organs as determined by SOFA score		within first 72 hours	No
Secondary	subsequent admission to critical care		within first 72 hours	No
Secondary	Changes in immune activation in those patients who develop any of the events mention in previous outcomes (i.e. septic shock, death, organ dysfunction, admission to critical care)		within first 72 hours	No