Changes of Dendritic Cells in Acute Lung Injury | NCT02083393

Studies
Changes of Dendritic Cells in Acute Lung Injury

NCT02083393

Sponsor

Southeast University, China

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Acute Lung Injury

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

Status Module

Record Verification Date

May 2015

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

Jun 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 11, 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

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

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

To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia

Detailed Description

Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.

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

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute lung injury		Patients with sepsis induced acute lung injury
Postsurgery patients		Postsurgery patients without acute lung injury and sepsis

Interventions

Not provided

Measure	Description	Time Frame
28-day mortality		28day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sepsis induced acute lung injury

Exclusion Criteria:

Younger than 18-year-old
Pregnancy
Cancer or organ transplant
Asthma
COPD
Heart Failure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Sepsis induced-ALI patients with mechanical ventilation including invasive aspergillosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haibo Qiu, Ph.D.	Southeast University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital Southeast University		Nanjing	Jiangsu	210000	China

Condition Browse Module

MeSH Terms

ID	Term
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

Not provided