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

Jianfeng Xie

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT02883218

2014ZDSYLL087.0

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

85 participants in 3 patient groups

Comunity-acquired severe sepsis patients

Description:

Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status

Non-severe sepsis patients

Description:

Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis.

Healthy controls

Description:

Heathy vonlunteers between 18 and 90 years of age.