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

NCT02883218 | Completed DMC

• 1 other identifier: 2014ZDSYLL087.0
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

immunosuppression; community-acquired sepsis; mortality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 28-day mortality for community-acquired severe sepsis group

  28-day

• ICU-acquired infection for community-acquired severe sepsis group

  28-day

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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:
• at least 18 years of age and no more than 90 years of age
• provided written informed consent.
• diagnosis of hematological,immunological disease or cancer
• treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment

Sponsors & Collaborators

• Jianfeng Xie: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• 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.

  PMID: 30813927 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2014
• Primary Completion: July 20, 2018
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

CN (1)