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

October 25, 2016 updated by: University of Edinburgh

Early Prediction of Severe Sepsis (ExPRESSepsis) Study

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

401

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
      • Newcastle, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in the initial 12 hours following presentation to hospital with suspected sepsis, i.e. patients with signs of systemic inflammation (i.e. meeting criteria for SIRS) where the treating clinician takes microbial samples and/or starts empiric antibiotics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Patients with sepsis syndrome, without criteria for severe sepsis/septic shock. These patients are recruited from the emergency department.
Cohort 2
Patients with community acquired sepsis syndrome REQUIRING critical care admission due to severity of sepsis. These patients are recruited from the critical care areas (ICU/HDU).
Cohort 3
Patients without sepsis syndrome. Age and gender matched to cohort 1, and recruited from Emergency Department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of septic shock
Time Frame: Within first 72 hours
Within first 72 hours
Confirmation of suspected infection
Time Frame: within first 72 hours
within first 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital outcome (lived/died)
Time Frame: Within first 72 hours
Within first 72 hours
Time to septic shock onset
Time Frame: Within the first 72 hours
Within the first 72 hours
Death from sepsis
Time Frame: Within first 72 hours
Within first 72 hours
Organ dysfunction, total and individual organs as determined by SOFA score
Time Frame: within first 72 hours
within first 72 hours
subsequent admission to critical care
Time Frame: within first 72 hours
within first 72 hours
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)
Time Frame: within first 72 hours
within first 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Becton, Dickinson and Company
Technology Strategy Board, United Kingdom

Investigators

  • Principal Investigator: 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: Manu Shankar-Hari, MD, Guy's and St Thomas' NHS Foundation Trust
  • Principal Investigator: John Wright, MD, Newcastle-upon-Tyne Hospitals NHS Trust
  • Principal Investigator: Alasdair Gray, MD, NHS Lothian/University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/0267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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