NCT02361970

Brief Summary

The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

January 27, 2015

Last Update Submit

May 20, 2017

Conditions

Sepsis

Keywords

sepsisgamma delta T cellsimmunosuppression

Outcome Measures

Primary Outcomes (1)

  • The percentage of activated gamma delta T cells

    within 24h after recruitment

Secondary Outcomes (1)

  • The percentage of apoptotic gamma delta T cells

    within 24h after recruitment

Study Arms (3)

severe sepsis and septic shock

patients were diagnosed severe sepsis or septic shock

patient control

Patients after elective surgeries presented with SIRS but without sepsis

volunteer

Health persons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted in ICUs of West China Hospital

You may qualify if:

  • clinical symptoms of severe sepsis and septic shock
  • age over 18 years

You may not qualify if:

  • preexisting autoimmune disease
  • patients received immuno-suppressive treatment in the previous 6 months
  • patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample was collected to examine extra-cell expression of gamma delta T cells and their intracellular cytokines with or without immuno-stimulants using flow cytometry.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Unit

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 12, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

CN(1)