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

NCT02180009 | Completed

• 1 other identifier: ZS2012009
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Severe Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  28 days

Study Arms (4)

normal control

healthy people

sepsis

mild response to infection

severe sepsis

infection with at least one organ dysfunction

septic shock

patients with septic shock

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with sepsis

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Institute of Basic Medical Science: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related 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. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.

  PMID: 12664219 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Lixin Xie, PhD & MD

  Head of Department of Respiratory Medicine,Chinese PLA Gerneral Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor of Department of Respiratory Medicine

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (1)