The Changes of CD4+T Lymphocyte Subsets in Septic Patients

NCT ID: NCT01494389

Last Updated: 2011-12-19

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

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell immunity in the patients with sepsis.There are immunoparalysis in septic patients,the important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to the illness progress and outcome. Comprehend the change regularity of septic patients' cell immunity can guide fiter and correcter treatment.

Detailed Description

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Conditions

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Sepsis SIRS(Systemic Inflammatory Response Syndrome)

Keywords

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CD4+T lymphocyte subsets sepsis immunoparalysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SIRS

(1) temperature \> 38oC or \< 36oC; (2) pulse rate \> 90 beats/min; (3) ventilation rate \> 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) \< 32 mmHg; (4) white blood cell (WBC) count \>1 2,000μL-1 or \< 4000 μL-1 , or \> 10% immature cells.

No interventions assigned to this group

sepsis

SIRS + infection

No interventions assigned to this group

Normal

not SIRS and have no infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male and female aged 18 years old and over;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.
* Clinically suspected infection;

Exclusion Criteria

* were under 18 years of age;
* were refused by the patients or his/her familiality;
* were suffering from acquired immunodeficiency syndrome,virlhepatitis,autoimmune diseases and hematology;
* use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant
* died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Xie Li Xin, Doctor

Role: STUDY_DIRECTOR

Department Of Respiratory Diseases, Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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20111013-008

Identifier Type: -

Identifier Source: org_study_id