Outcome of Patients Treated With ECLS | NCT04405817

Studies
Outcome of Patients Treated With ECLS

NCT04405817

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

May 28, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Cardiogenic Shock
Cardiac Arrest
Heart Failure
Acute Respiratory Failure
Acute Respiratory Distress Syndrome

Interventions

ECMO

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 2020

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

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 28, 2020Actual

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, 2020

Last Update Posted Date

May 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Liu, Investigator of Department of Cardiac Surgery, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective circulatory and (or) respiratory failure, with a growing number of critically ill patients benefit from it. The aim of this study is to investigate the outcome of patients treated With ECMO, and to evaluate the short-term and long-term outcomes of patients with ECLS.

Detailed Description

Not provided

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

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO	Device	ECMO for circulatory and/or respiratory support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device		30 days after ECMO implantation

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality		30 days after ECMO implantation
All-cause mortality		12 months after ECMO implantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving ECMO for circulatory and/or respiratory support

Exclusion Criteria:

Refusal of consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients receiving ECMO for circulatory and/or respiratory support

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong Liu, MD	Contact	18801281613		DR.HONGLIU@FOXMAIL.COM
Yong-feng Shao, MD	Contact	02568303100		yfshaojph@sina.com

Overall Officials

Name	Affiliation	Role
Yong-feng Shao	The First Affiliated Hospital with Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of nanjing medical university	Recruiting	Nanjing	Jiangsu	210029	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic
D006323	Heart Arrest
D006333	Heart Failure
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided