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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188992
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
Information provided by (Responsible Party):
University of Edinburgh

Brief 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


Condition or disease
Sepsis

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Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Prediction of Severe Sepsis (ExPRESSepsis) Study
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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.



Primary Outcome Measures :
  1. Development of septic shock [ Time Frame: Within first 72 hours ]
  2. Confirmation of suspected infection [ Time Frame: within first 72 hours ]

Secondary Outcome Measures :
  1. Hospital outcome (lived/died) [ Time Frame: Within first 72 hours ]
  2. Time to septic shock onset [ Time Frame: Within the first 72 hours ]
  3. Death from sepsis [ Time Frame: Within first 72 hours ]
  4. Organ dysfunction, total and individual organs as determined by SOFA score [ Time Frame: within first 72 hours ]
  5. subsequent admission to critical care [ Time Frame: within first 72 hours ]
  6. 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 ]

Biospecimen Retention:   Samples Without DNA
Samples of serum and plasma will be stored frozen.


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188992


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Royal Victoria Infirmary
Newcastle, United Kingdom, NE1 4LP
Sponsors and Collaborators
University of Edinburgh
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
Investigators
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Principal Investigator: Tim S Walsh, MD NHS Lothian/University of Edinburgh
Principal Investigator: John Wright, MD Newcastle-upon-Tyne Hospitals NHS Trust
Principal Investigator: Manu Shankar-Hari, MD Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Andrew Conway Morris, MD University of Cambridge
Principal Investigator: John Simpson, MD Newcastle University
Principal Investigator: Alasdair Gray, MD NHS Lothian/University of Edinburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02188992    
Other Study ID Numbers: 2013/0267
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: July 2014
Keywords provided by University of Edinburgh:
Sepsis
Immune activation
Systemic Inflammation
Emergency Medicine
Critical Care
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes