Status:
COMPLETED
Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
Conditions:
Sepsis
Eligibility:
All Genders
16+ years
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 tim...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT02188992
Start Date
January 1 2014
End Date
January 1 2016
Last Update
October 26 2016
Active Locations (3)
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1
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
2
St Thomas' Hospital
London, United Kingdom, SE1 7EH
3
Royal Victoria Infirmary
Newcastle, United Kingdom, NE1 4LP