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NCT Number: NCT01801839

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms SIRS(Systemic Inflammatory Response Syndrome) Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: within 24 hours after enter experimental group

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
First posted
Mar 1, 2013
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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