Sepsis Severe Sepsis Septic Shock A41.9 R57.2
Conditions
Interventions
Group 1: No intervention. Patients having survived sepsis are diagnostically evaluated regarding their immune function on day 5, 30, 90, 180, and 360 after the initial event.
Group 2: No intervention
Sponsors
Universitätsklinikum Jena
Friedrich-Schiller-Universität
Center for Sepsis Control and Care (CSCC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria Patient: 1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference: - Sepsis: SIRS with documented infection -->SIRS: presence of at least two criteria: 1) body temperature 38°C), 2) tachycardia (>90 beats/min), 3) tachypnea (>20 breaths/min or PaCO212,000 cells/µl. --> Infection: defined by the International Sepsis Forum Consensus Conference on Definitions of Infection in the Intensive Care Unit. -Severe sepsis: sepsis with at least one manifestation of inadequate organ perfusion or function: 1) hypoxemia (PaO22mmol/l), 5) acute alteration in mental status without sedation. -Septic shock: sepsis with sustained decrease in systolic blood pressure ( 18 years 3. Obtained oral and written consent Key Inclusion Criteria Healthy Control: 1. Male or female persons, age =/> 18 years 2. Obtained oral and written consent Key Inclusion Criteria SIRS Control: 1. SIRS based on the definitions by the ACCP/SCCM Consensus Conference: -->SIRS: presence of at least two criteria: 1) body temperature 38°C), 2) tachycardia (>90 beats/min), 3) tachypnea (>20 breaths/min or PaCO212,000 cells/µl. 2. Male or female persons, age =/> 18 years 3. Obtained oral and written consent
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria Patient: 1. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day) 2. Chemo- or radiotherapy due to malignancy 3. End-stage chronic liver disease (Child-Pugh C) 4. End-stage chronic kidney disease (requiring renal replacement therapy) 5. Extracorporeal circulation and/or membrane oxygenation 6. Ischemic stroke or intracranial bleeding within last three months 7. Pregnancy and nursing 8. Participation in interventional study Key Exclusion Criteria Healthy Control: 1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference at the time of screening or in medical history 2. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day) 3. Chemo- or radiotherapy due to malignancy 4. End-stage chronic liver disease (Child-Pugh C) 5. End-stage chronic kidney disease (requiring renal replacement therapy) 6. Extracorporeal circulation and/or membrane oxygenation 7. Ischemic stroke or intracranial bleeding within last three months 8. Pregnancy and nursing 9. Participation in interventional study Key Exclusion Criteria SIRS Control: 1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference at the time of screening or in medical history 2. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day) 3. Chemo- or radiotherapy due to malignancy 4. End-stage chronic liver disease (Child-Pugh C) 5. End-stage chronic kidney disease (requiring renal replacement therapy) 6. Ischemic stroke or intracranial bleeding within last three months 7. Pregnancy and nursing 8. Participation in interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inadequate reconstitution of immune function 1,3, 6, and 12 months after sepsis regarding monocyte HLA-DR expression, evaluated by flow cytometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the suppressed immune function by flow cytometry 1, 3, 6, and 12 months after sepsis regarding lymphocyte function after antigen specific and - unspecific stimulation. Furthermore, the suppressed immune function will be evaluated based on the following factors: 1. APACHE II Score and SAPS II Score 2. Survival after 1, 3, 6, and 12 months 3. Re-Occurrence of sepsis after 1, 3, 6, and 12 Monaten 4. Immunological characterisation by monocyte HLA-DR expression, lymhocyte compartment composition and response to antigen specific and - unspecific stimulation, including T cell receptor diversity), and neutrophil functionality 4 to 14 days after sepsis onset. 5. Composition of lymphocyte compartment, including T cell receptor diversity), and neutrophil functionality one, three, six, and twelve months after sepsis onset. | — |
Countries
Germany
Contacts
Public ContactKatharina Ferrari-Kühne
Universitätsklinikum Jena Center for Sepsis Control and Care (CSCC)
Outcome results
None listed