Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

Sepsis Clinical Trial

Official title:

Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180009
• Other study ID #: ZS2012009
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: January 26, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.

Description:

In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• More than one of the following:

clinical manifestations: (1) a body temperature greater than 38? or less than 36?; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10^9/L, a count less than 4×10^9/L, or the presence of more than 10 percent immature neutrophils

Exclusion Criteria:

• (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Institute of Basic Medical Science

Country where clinical trial is conducted

China, 

References & Publications (1)

Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. Epub 2003 Mar 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		28 days	No