Sepsis, SIRS without infection Infections and Infestations
Conditions
Interventions
We will study two patient groups: patients with severe sepsis from abdominal and pulmonary disease (n=160), and a positive control group. The positive control group will be patients with inflammation
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or over 2. Diagnosis of severe sepsis. Sepsis is defined as: 2.1. A defined focus of infection: indicated by either: 2.1.1. An organism grown in blood or sterile site OR 2.1.2. An abscess or infected tissue (e.g., pneumonia, peritonitis, urinary tract, vascular line infection, soft tissue, etc) 2.2. At least two systemic inflammatory response syndrome (SIRS) criteria. The four SIRS criteria are: 2.2.1. Core temperature >38°C or 90 beats/minute. If patient had an atrial arrhythmia, record the ventricular rate. If patients have a known medical condition or are receiving treatment that would prevent tachycardia (for example, heart block or beta blockers), they must meet two of the remaining three SIRS criteria. Use the most deranged value recorded in the 24 hours before ICU admission. 2.2.3. Respiratory rate > 20 breaths per minute or a PaCO2 12 x 109/l or 10% immature neutrophils (band forms). Use the most deranged value recorded in the 24 hours before ICU admission. 3. Severe sepsis is defined as sepsis plus at least one organ failure, except when that organ failure was already present 48 hours before the onset of sepsis. 4. Organ failure is defined as a Sequential Organ Failure Assessment (SOFA) score > 2 for the organ in question 5. Presenting to hospital with abdominal or pulmonary sepsis of less than 72 hours duration 6. Patient already has or will require arterial cannulation as part of standard treatment Inclusion criteria for critically ill patients without infection: 1. Patients admitted to the ICU following out-of hospital cardiac arrest 2. SIRS criteria as above 3. Organ failure criteria as above 4. Patients must not be receiving antibiotics for treatment of known or suspected infection 5. Patient already has or will require arterial cannulation as part of standard treatment
Exclusion criteria
Exclusion criteria: 1. Age less than 16 years 2. Pregnant 3. Severe immune deficiency, for example a diagnosis of AIDS 4. Anti-rejection transplant drugs 5. Methotrexate 6. High-dose corticosteriod treatment (>10 mg prednisolone/day or equivalent) 7. Severe liver failure 8. Childs III or worse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Document the biological (biomarker) profiles of patients with severe sepsis and septic shock using genomic and proteomic analysis from samples taken on day 1,2,5 and ICU discharge 2. Identify which combinations of biomarkers can give the best predictive information of how the patient will progress in their illness using genomic and proteomic analysis from samples taken on day 1, 2, 5 and ICU discharge 3. Assess quality of life after 6 months of ICU discharge in this cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the utility of the biomarker panel in the clinical environment as point-of-care tests on suitable devices used near the bedside | — |
Countries
United Kingdom
Outcome results
None listed