Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients

Study Overview
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Brief Summary
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To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.

Official Title
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Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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For community-acquired severe sepsis group: Inclusion Criteria: at least 18 years of age and no more than 90 years of age sepsis was defined according to consensus criteria diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h provided written informed consent. Exclusion Criteria: diagnosis of hematological,immunological disease or cancer treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization For non-severe sepsis ICU control group: Inclusion Criteria: at least 18 years of age and no more than 90 years of age without diagnosis of sepsis and admitted to ICU provided written informed consent. Exclusion Criteria: diagnosis of hematological,immunological disease or cancer treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization For healthy control group: Inclusion Criteria: at least 18 years of age and no more than 90 years of age provided written informed consent. Exclusion Criteria: diagnosis of hematological,immunological disease or cancer treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Comunity-acquired severe sepsis patients<br>Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status | |
| Non-severe sepsis patients<br>Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis. | |
| Healthy controls<br>Heathy vonlunteers between 18 and 90 years of age. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Th2/Th1 upon enrollment | The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed. | Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group | 
| Th2/Th1 on Day 3 | populations measured by flow cytometry. Only community-acquired severe sepsis group is needed. | Day 3 after enrollment for community-acquired severe sepsis group | 
| Th2/Th1 on Day 7 | populations measured by flow cytometry. Only community-acquired severe sepsis group is needed. | Day 7 after enrollment for community-acquired severe sepsis group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality for community-acquired severe sepsis group |  | 28-day | 
| ICU-acquired infection for community-acquired severe sepsis group |  | 28-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunosuppression, community-acquired sepsis, mortality