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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883218
• Other study ID #: 2014ZDSYLL087.0
• Status: Completed
• Start date: September 2014
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 1, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jianfeng Xie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	28-day mortality for community-acquired severe sepsis group		28-day
Secondary	ICU-acquired infection for community-acquired severe sepsis group		28-day