Plasma Level of Mitochondrial DNA in Patients With ARDS a... | NCT02883231

Studies
Plasma Level of Mitochondrial DNA in Patients With ARDS and Its Clinical Significance

NCT02883231

Sponsor

Chun Pan

Status

Unknown status

Last Update Posted

Aug 30, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.

Interventions

taking peripheral blood

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

Aug 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

Apr 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Aug 25, 2016

First Submission Date that Met QC Criteria

Aug 25, 2016

First Posted Date

Aug 30, 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

Aug 25, 2016

Last Update Posted Date

Aug 30, 2016Estimated

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 the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and to explore its clinical significance.

Detailed Description

60 patients who diagnosed as ARDS were included in this study.Then keep blood samples from these patients in the first day、the third day and the sveventh day,detect the mitochotndrial DNA level in plasma by real-time quantitative PCR. Recored Severity of illness and survival status of every patient within 28 days.Objective to evaluate the correlation between the level of mitochondrial DNA in plasma and the prognosis of the patients.

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

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
taking peripheral blood	Other	taking peripheral blood of no more than 3ml

Measure	Description	Time Frame
mortality		28-day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to ICU diagnosed of ARDS (Berlin criteria),
Patients age between 18 years old and 80 years.

Exclusion Criteria:

Pregnant women,
Patients with malignant tumor,
Immunosuppression or immunocompromised patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS。

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lili Huang, Dr	Contact	13770840246		caowangyou007@126.com
Haibo Qiu, Dr	Contact	+862583262550		haiboq2000@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital	Recruiting	Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33611982	Derived	Peng F, Liang C, Chang W, Sun Q, Xie J, Qiu H, Yang Y. Prognostic Significance of Plasma Hepatocyte Growth Factor in Sepsis. J Intensive Care Med. 2022 Mar;37(3):352-358. doi: 10.1177/0885066621993423. Epub 2021 Feb 22.