NCT02319876

Brief Summary

The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

December 15, 2014

Last Update Submit

July 27, 2015

Conditions

SepsisImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes

    TIM-3 level on T cells was compared between different populations.

    within 24h after recruitment

Secondary Outcomes (1)

  • 28-day mortality

    28 days after diagnosis of sepsis

Study Arms (3)

Severe sepsis

Patients with severe sepsis

SIRS patient

Patients after elective surgeries presented with SIRS but without sepsis

Volunteer

Volunteers

Eligibility Criteria

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

Patients admitted in ICU at Changhai Hospital

You may qualify if:

  • patients with severe sepsis
  • patients undergo invasive spine surgery
  • healthy volunteers

You may not qualify if:

  • patients with immunodeficient diseases
  • patients who accept glucocorticoid or immunosuppressant
  • patients with an age older than 18 years
  • patients providing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample was collected to examine TIM-3 on CD4+ and CD8+ lymphocytes, and CD14+ monocytes. Monocyte HLA-DR will also be determined.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaoming Deng, M.D., Ph.D.

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lulong Bo, M.D., Ph.D.

CONTACT

+862131163489lulongbo@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor and chief

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 18, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-06

Locations

CN(1)