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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02883218

Enrollment

Registered

2016-08-30

Start date

2014-09-30

Completion date

2018-08-01

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

immunosuppression, community-acquired sepsis, mortality

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Th2/Th1 upon enrollment	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.
Th2/Th1 on Day 3	Day 3 after enrollment for community-acquired severe sepsis group	populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
Th2/Th1 on Day 7	Day 7 after enrollment for community-acquired severe sepsis group	populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.

Secondary

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

Countries

China

Outcome results