Expression of TIM-3 on Lymphocytes in Sepsis | NCT02319876

Studies
Expression of TIM-3 on Lymphocytes in Sepsis

NCT02319876

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2015Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Sepsis
Immunosuppression

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
81201492	Other Grant/Funding Number	National Natural Science Foundation of China

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 15, 2014

First Submission Date that Met QC Criteria

Dec 15, 2014

First Posted Date

Dec 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe sepsis		Patients with severe sepsis
SIRS patient		Patients after elective surgeries presented with SIRS but without sepsis
Volunteer		Volunteers

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
28-day mortality		28 days after diagnosis of sepsis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with severe sepsis
patients undergo invasive spine surgery
healthy volunteers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted in ICU at Changhai Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lulong Bo, M.D., Ph.D.	Contact	+862131163489		lulongbo@gmail.com

Overall Officials

Name	Affiliation	Role
Xiaoming Deng, M.D., Ph.D.	Changhai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology and Intensive Care, Changhai Hospital	Recruiting	Shanghai	Shanghai Municipality	200433	China

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

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Browse Branches

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