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The Changes of CD4+T Lymphocyte Subsets in Septic Patients

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ClinicalTrials.gov Identifier: NCT01494389
Recruitment Status : Unknown
Verified July 2011 by Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by:
Chinese PLA General Hospital

Brief Summary:
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.

Condition or disease
Sepsis SIRS(Systemic Inflammatory Response Syndrome)

Study Type : Observational
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of CD4+T Lymphocyte Subsets in Cell Immunity in Patients With Sepsis
Study Start Date : August 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Group/Cohort
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.
sepsis
SIRS + infection
Normal
not SIRS and have no infection




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects were selected from among inpatients who were hospitalized between March 2010 and March 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494389


Locations
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Xie Li Xin, Doctor Department Of Respiratory Diseases, Chinese PLA General Hospital

ClinicalTrials.gov Identifier: NCT01494389     History of Changes
Other Study ID Numbers: 20111013-008
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: July 2011

Keywords provided by Chinese PLA General Hospital:
CD4+T lymphocyte subsets
sepsis
immunoparalysis

Additional relevant MeSH terms:
Sepsis
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock