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

NCT ID: NCT02883218

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Comunity-acquired severe sepsis patients

Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status

No interventions assigned to this group

Non-severe sepsis patients

Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis.

No interventions assigned to this group

Healthy controls

Heathy vonlunteers between 18 and 90 years of age.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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.


* 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 or during the hospitalization

For non-severe sepsis ICU control group:


* 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:


* diagnosis of hematological,immunological disease or cancer
* treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jianfeng Xie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianfeng Xie

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30813927 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014ZDSYLL087.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.