This trial is active, not recruiting.

Conditions sepsis, sirs(systemic inflammatory response syndrome)
Sponsor Chinese PLA General Hospital
Start date August 2011
End date March 2012
Trial identifier NCT01494389, 20111013-008


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
(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.
SIRS + infection
not SIRS and have no infection

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Role of CD4+T Lymphocyte Subsets in Cell Immunity in Patients With Sepsis
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.