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Completed

NCT Number: NCT02883218

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Th2/Th1 upon enrollment

    Time frame: 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

    The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed.

  2. Th2/Th1 on Day 3

    Time frame: Day 3 after enrollment for community-acquired severe sepsis group

    populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.

  3. Th2/Th1 on Day 7

    Time frame: Day 7 after enrollment for community-acquired severe sepsis group

    populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.

Secondary outcomes

  1. 28-day mortality for community-acquired severe sepsis group

    Time frame: 28-day

  2. ICU-acquired infection for community-acquired severe sepsis group

    Time frame: 28-day

Sponsors and collaborators

Lead sponsor

Jianfeng Xie

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2016
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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