Status:
UNKNOWN
Validation of Molecular and Protein Biomarkers in Sepsis
Lead Sponsor:
Public Health England
Collaborating Sponsors:
Aneurin Bevan University Health Board
Cardiff University
Conditions:
Sepsis
Cardiac Arrest
Eligibility:
All Genders
18+ years
Brief Summary
Background: Sepsis (blood poisoning) is a clinical syndrome characterised by a dysregulated host response to infection causing life-threatening organ dysfunction which results in admission to an inte...
Detailed Description
Sepsis, defined as life threatening organ failure resulting from a dysregulated host response to infection, remains a leading cause of death in critically ill patients and has been included as a healt...
Eligibility Criteria
Inclusion
- Inclusion Criteria for community-acquired Sepsis and Septic Shock
- Age =\> 18
- Admission to hospital within 72 hours of symptoms onset and development of clinical signs of sepsis
- Diagnosis of sepsis
- SEPSIS is defined as a (1) DEFINED FOCUS OF INFECTION AND (2) SOFA\>2, with at least ONE organ specific SOFA subscore =2.
- (1) DEFINED FOCUS OF INFECTION is indicated by either i. An organism grown in blood or sterile site OR ii. An abscess or infected tissue (e.g. pneumonia, peritonitis, urinary tract, vascular line infection, soft tissue, etc).
- (2) The SOFA score criteria are described in the Appendix \[7\]
- SEPTIC SHOCK is defined as SEPSIS plus the presence of hypotension requiring the use of vasopressors to maintain mean arterial pressure of 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L persisting after adequate fluid resuscitation \[8\]
- Inclusion Criteria for Critically Ill patients without infection
- Patients admitted to the ICU following out-of hospital cardiac arrest OR Patients admitted to the ICU following major trauma (ISS\>12) OR Patients admitted to the ICU following pancreatitis
- Have multiorgan failure as defined by SOFA\>2, with at least ONE organ specific SOFA subscore =2.
- Patients must not be receiving antibiotics for treatment of known or suspected infection
- patient already has or will require arterial cannulation as part of standard treatment
Exclusion
- 1\. Patients who are on immune-modulating therapy (e.g., methotrexate, prednisolone \>5mg/day, or other immunosuppressants) for any length of time within 6 months of index admission 2. Patients with acquired cellular immune deficiency (E.g. active HIV infection or AIDS); 3. Patients with concurrent blood-borne viral infections (E.g. Hepatitis B or C) 4. Patients with any haematological malignancy in their past medical history; 5. Patients who are on chronic haemodialysis; 6. Solid organ transplant recipients; 7. Patients who have biopsy, image or endoscopy proven liver cirrhosis; 8. Patients who are not expected to survive beyond 90 days due to the advancement of their underlying disease.
Key Trial Info
Start Date :
February 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04289506
Start Date
February 25 2020
End Date
November 1 2021
Last Update
March 5 2020
Active Locations (3)
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1
Aneurin Bevan University Health Board
Newport, Gwent, United Kingdom, NP20 3UB
2
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
3
Public Health England
London, United Kingdom, SE1