- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405817
Outcome of Patients Treated With ECLS
May 26, 2020 updated by: Hong Liu, Nanjing Medical University
Outcome of Patients Treated With Extracorporeal Life Support
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients receiving ECMO for circulatory and/or respiratory support
Description
Inclusion Criteria:
- Patients receiving ECMO for circulatory and/or respiratory support
Exclusion Criteria:
- Refusal of consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Time Frame: 30 days after ECMO implantation
|
30 days after ECMO implantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause mortality
Time Frame: 30 days after ECMO implantation
|
30 days after ECMO implantation
|
|
All-cause mortality
Time Frame: 12 months after ECMO implantation
|
12 months after ECMO implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yong-feng Shao, The First Affiliated Hospital with Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
May 26, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 28, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Shock
- Myocardial Infarction
- Infarction
- Lung Injury
- Infant, Premature, Diseases
- Respiratory Insufficiency
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Shock, Cardiogenic
Other Study ID Numbers
- ECLS-Jsph
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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