Clinical trial NCT02883218: Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients
Official title: Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: immunosuppression
community-acquired sepsis
mortality
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Th2/Th1 upon enrollment
timeFrame: 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
measure: Th2/Th1 on Day 3
timeFrame: Day 3 after enrollment for community-acquired severe sepsis group
measure: Th2/Th1 on Day 7
timeFrame: Day 7 after enrollment for community-acquired severe sepsis group
Secondary outcomes:
measure: 28-day mortality for community-acquired severe sepsis group
timeFrame: 28-day
measure: ICU-acquired infection for community-acquired severe sepsis group
timeFrame: 28-day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
citation: 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.