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Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms

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ClinicalTrials.gov Identifier: NCT03379896
Recruitment Status : Not yet recruiting
First Posted : December 20, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Kang Yan, West China Hospital

Brief Summary:
Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms

Condition or disease Intervention/treatment
Sepsis Antigen-presenting Function γδ T Cells Other: Collect peripheral blood sample

Detailed Description:
The latest definition of sepsis highlights the role of dysregulated host response to infection in organ dysfunction aggravation. Maintenance of immune homeostasis of septic patients through immunotherapy is the key breakthrough to improve success rate. Antigen-presenting cell (APC) is the bridge that connects the innate and adaptive immunity. Decrease of count and function of APC has been shown to be associated with worsened clinical outcomes in patients with sepsis. Gamma-delta T cells (γδ T cells) are the newly identified population of T lymphocytes. Recent studies have found that γδ T cells possess unique and powerful antigen-presenting function, making them the hot topic in infection and cancer research. Based on the results, the investigator plan to evaluate the antigen-presenting function changes of γδ T cells in septic status by analyzing the antigen-presenting related molecules on γδ T cells, antigen protein uptake ability, and their function on the proliferation and activation of CD8+ T lymphocytes. Furthermore, the investigator will explore the mechanism and signal pathways for the APC function changes of γδ T cells. Findings from this research could help explain the mechanism of sepsis induced immune dysfunction, enrich our understanding of the important role of γδ T cells, and build a good foundation for immunotherapy in sepsis.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
Estimated Study Start Date : January 4, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Sepsis
Patient diagnosed with sepsis according to the new sepsis definition (infection+SOFA≥2).
Other: Collect peripheral blood sample
Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.

Control
Age-matched healthy control
Other: Collect peripheral blood sample
Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.




Primary Outcome Measures :
  1. 28-day clinical outcome [ Time Frame: 28-day after ICU admission ]
    death



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with sepsis from department of Critical Care Medicine of West China Hospital are included if they meet the study criteria on ICU admission. Healthy control subjects are adult volunteers from our hospital staff and their family members with no significant acute or chronic illnesses.
Criteria

Inclusion Criteria:

  1. ≥18 year old;
  2. a known or suspected infection based on clinical data at the time of admission and sepsis-induced dysfunction of at least one organ.

Exclusion Criteria:

  1. autoimmune disease,
  2. history of transplantation,
  3. acute tuberculosis,
  4. chronic hepatitis B or C infection,
  5. HIV infection,
  6. active malignancy, and
  7. long-term use of cortical steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379896


Contacts
Contact: Xuelian Liao, MD 8613541023033 xuelianliao@hotmail.com

Sponsors and Collaborators
West China Hospital

Responsible Party: Kang Yan, Yan Kang, Director of Department of Critical Care Medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT03379896     History of Changes
Other Study ID Numbers: 81701880
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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