NCT03379896

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

December 16, 2017

Last Update Submit

December 20, 2017

Conditions

SepsisAntigen-presenting Functionγδ T Cells

Outcome Measures

Primary Outcomes (1)

  • 28-day clinical outcome

    death

    28-day after ICU admission

Study Arms (2)

Sepsis

Patient diagnosed with sepsis according to the new sepsis definition (infection+SOFA≥2).

Other: Collect peripheral blood sample

Control

Age-matched healthy control

Other: Collect peripheral blood sample

Interventions

Collect peripheral blood sampleOTHER

Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.

ControlSepsis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • autoimmune disease,
  • history of transplantation,
  • acute tuberculosis,
  • chronic hepatitis B or C infection,
  • HIV infection,
  • active malignancy, and
  • long-term use of cortical steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xuelian Liao, MD

CONTACT

8613541023033xuelianliao@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yan Kang, Director of Department of Critical Care Medicine

Study Record Dates

First Submitted

December 16, 2017

First Posted

December 20, 2017

Study Start

January 4, 2018

Primary Completion

June 30, 2020

Study Completion

December 30, 2020

Last Updated

December 22, 2017

Record last verified: 2017-12