- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01494389
The Changes of CD4+T Lymphocyte Subsets in Septic Patients
December 16, 2011 updated by: Chinese PLA General Hospital
The Role of CD4+T Lymphocyte Subsets in Cell Immunity in Patients With Sepsis
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.
Study Overview
Status
Unknown
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Chinese PLA General hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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sepsis
SIRS + infection
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Normal
not SIRS and have no infection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Xie Li Xin, Doctor, Department of Respiratory Diseases, Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
March 1, 2012
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 16, 2011
First Posted (Estimate)
December 19, 2011
Study Record Updates
Last Update Posted (Estimate)
December 19, 2011
Last Update Submitted That Met QC Criteria
December 16, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20111013-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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