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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We enroll patients with community-acquired severe sepsis and then the patients admitted to ICU without the diagnosis of severe sepsis as ICU control group, and the heathy volunteers as healthy control group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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	Time Frame
28-day mortality for community-acquired severe sepsis group	28-day
ICU-acquired infection for community-acquired severe sepsis group	28-day

Collaborators and Investigators

• Sponsor: Jianfeng Xie

Publications and helpful links

General Publications

• Xue M, Xie J, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H. Early and dynamic alterations of Th2/Th1 in previously immunocompetent patients with community-acquired severe sepsis: a prospective observational study. J Transl Med. 2019 Feb 27;17(1):57. doi: 10.1186/s12967-019-1811-9.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: immunosuppression; mortality; community-acquired sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2014ZDSYLL087.0