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The Changes of CD4+T Lymphocyte Subsets in Septic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01494389
First received: December 16, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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
Sepsis
SIRS(Systemic Inflammatory Response Syndrome)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of CD4+T Lymphocyte Subsets in Cell Immunity in Patients With Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01494389     History of Changes
Other Study ID Numbers: 20111013-008
Study First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 13, 2013