PD-1/PD-L1 Pathway Study on Septic Patients | NCT01161745

Studies
PD-1/PD-L1 Pathway Study on Septic Patients

NCT01161745

Sponsor

Changhai Hospital

Status

Completed

Last Update Posted

Jul 14, 2010Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jul 13, 2010

First Submission Date that Met QC Criteria

Jul 13, 2010

First Posted Date

Jul 14, 2010Estimated

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 13, 2010

Last Update Posted Date

Jul 14, 2010Estimated

Name	Class
National Natural Science Foundation of China	OTHER_GOV

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 investigators want to identify that whether PD-1/PD-L1 pathway will change in human sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced immunosuppression.

Detailed Description

First, we will detect PD-L1 expression on PBMC of septic patients and healthy controls.

Second, blockade of PD-1/PD-L1 pathway in vitro and stimulate with some biomolecules and then analyze the PBMC function and apoptosis by flow cytometry.

Then, compare with healthy controls and find the differences.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who develop sepsis

Exclusion Criteria:

patients with cirrhosis or renal dysfunction
patients with dyscrasia
patients with autoimmunity diseases
patients with severe cardiac and pulmonary diseases
patients with hematological diseases
patients with diabetes mellitus
patients with malignant tumors

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 who develop sepsis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiao-ming Deng, doctor	Changhai Hospital, the Second Military Medical University	Principal Investigator

Locations

Not provided

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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