Dendritic Cells-Derived Exosomes in Human Sepsis | NCT02957279

Studies
Dendritic Cells-Derived Exosomes in Human Sepsis

NCT02957279

Sponsor

Jinling Hospital, China

Status

Unknown status

Last Update Posted

Nov 7, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Antibiotics

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

Status Module

Record Verification Date

Nov 2016

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

Nov 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Nov 4, 2016

First Submission Date that Met QC Criteria

Nov 4, 2016

First Posted Date

Nov 7, 2016Estimated

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

Nov 4, 2016

Last Update Posted Date

Nov 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianan Ren, President of department of surgery, Jinling Hospital, Jinling Hospital, ChinaPrincipal Investigator

Lead Sponsor

Jinling Hospital, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

Detailed Description

This is a prospective, single-centered, clinical cohort study.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis group		The patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0).	Drug: Antibiotics
Healthy control group		Healthy volunteers.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotics	Drug	In the sepsis group, antibiotics were used when needed.	Sepsis group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of dendritic cell-derived exosomes		The first 4 hour after admission

Secondary Outcomes

Measure	Description	Time Frame
Compositions of microRNA in the dendritic cell-derived exosomes		The first 4 hour after admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were selected with the diagnostic standard "Sepsis 3.0".
Healthy volunteers do not have serious illness.

Exclusion Criteria:

Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
Patients give up treatments.
Patients or volunteers withdrew from the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients were admitted to Jinling Hospital from November, 2016.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianan Ren, MD	Contact	862580860108		jiananr@gmail.com
Yuan Li, MD	Contact	8615751866716		liyuan9006@gmail.com

Overall Officials

Name	Affiliation	Role
Jianan Ren, MD	Jinling Hospital, Medical School of Nanjing University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinling Hospital, Medical School of Nanjing University	Recruiting	Nanjing	Jiangsu	210002	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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000900	Anti-Bacterial Agents

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided