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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; SIRS(Systemic Inflammatory Response Syndrome)

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• China
  • Peking, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All subjects were selected from among inpatients who were hospitalized between August 2012 and March 2013 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
systemic inflammatory response to infection with organ dysfunction, hypoperfusion, or hypotension	within 24 hours after enter experimental group

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Director: Lixin Xie, MD, Respiratory Disease Department of chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 2009BAI86B03 (Other Grant/Funding Number: Chinese National Science & Technology Pillar Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No