ong-term Immunological Sequelae in Sepsis-Survivors

Recruiting

• Conditions: SepsisSevere SepsisSeptic Shock; A41.9; R57.2; Sepsis, unspecified; Septic shock

• Registration Number: DRKS00003579
• Lead Sponsor: niversitätsklinikum JenaFriedrich-Schiller-UniversitätCenter for Sepsis Control and Care (CSCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 59

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 <36°C or >38°C),
2) tachycardia (>90 beats/min),
3) tachypnea (>20 breaths/min or PaCO2< 4.3kPa [32 mmHg], or need for mechanical ventilation),
4) white blood count <4000 cells/µl or >12,000 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 (PaO2<10kPa),
2) metabolic acidosis (ph<7.30),
3) oliguria (<30 ml/hr),
4) lactic acidosis (serum lactate >2mmol/l),
5) acute alteration in mental status without sedation.

-Septic shock: sepsis with sustained decrease in systolic blood pressure (<90mmHg, or drop of 40 mmHg from baseline) despite fluid resuscitation and need for vasoactive amines to maintain adequate blood pressure.

2. Male or female persons, age =/> 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 <36°C or >38°C),
2) tachycardia (>90 beats/min),
3) tachypnea (>20 breaths/min or PaCO2< 4.3kPa [32 mmHg], or need for mechanical ventilation),
4) white blood count <4000 cells/µl or >12,000 cells/µl.

2. Male or female persons, age =/> 18 years
3. Obtained oral and written consent

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inadequate reconstitution of immune function 1,3, 6, and 12 months after sepsis regarding<br>monocyte HLA-DR expression, evaluated by flow cytometry.<br>

Secondary Outcome Measures

Name	Time	Method
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. <br><br>Furthermore, the suppressed immune function will be evaluated based on the following factors:<br>1.APACHE II Score and SAPS II Score<br>2.Survival after 1, 3, 6, and 12 months<br>3.Re-Occurrence of sepsis after 1, 3, 6, and 12 Monaten<br>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.<br>5. Composition of lymphocyte compartment, including T cell receptor diversity), and neutrophil functionality one, three, six, and twelve months after sepsis onset.