Detection Of Monocytes/Macrophages Function And Tim-3 Expression In Septic Patients

NCT ID: NCT01801839

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31

Brief Summary

The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And continuous such imbalance could lead to immunoparalysis, which is characterized by loss of delayed type hypersensitivity, failure of primary infections eradication, and a predisposition of secondary nosocomial infections development. However, in which phase of sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively understand this problem by checking monocytes/macrophages' antigen presentation and cytokine secretion，and by checking monocytes/macrophages' expression of Tim-3 (the T cell transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in sepsis patients' peripheral blood mononuclear cells.

Conditions

Sepsis; SIRS(Systemic Inflammatory Response Syndrome)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SIRS,sepsis,normal

SIRS

(1) temperature > 38 centigrade or < 36 centigrade; (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 2,000/μL or < 4000/μL , or > 10% immature cells.

sepsis

SIRS + infection.

normal

not SIRS and have no infection.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age over 18 years old;
• Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 ℃ or lower than 36 ℃ (b)respiratory rate above 20/min, or carbon dioxide partial pressure 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,viral hepatitis,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: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jia Li

Medical doctor of Department of Respirtory Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Xie, MD

Role: STUDY_DIRECTOR

Respiratory Disease Department of Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, , China

Countries

China

Other Identifiers

2009BAI86B03

Identifier Type: -

Identifier Source: org_study_id