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

NCT01801839 | Completed

• 1 other identifier: 2009BAI86B03
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• systemic inflammatory response to infection with organ dysfunction, hypoperfusion, or hypotension

  within 24 hours after enter experimental group

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lixin Xie, MD

  Respiratory Disease Department of Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor of Department of Respirtory Disease

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 1, 2013
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (1)