Cardiogenic ShockNCT04405817
Outcome of Patients Treated With ECLS
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Cardiogenic Shock, Cardiac Arrest, Heart Failure
- What is being tested?
- ECMO
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients receiving ECMO for circulatory and/or respiratory support
Who may be able to join
- Patients receiving ECMO for circulatory and/or respiratory support
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
About this study
Official title: 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.
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Heart Failure, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Being tested
- ECMO
- Medical subject headings
- Shock, Cardiogenic, Heart Arrest, Heart Failure, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
ECMO for circulatory and/or respiratory support
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Measured: 30 days after ECMO implantation
Secondary outcomes (2)
All-cause mortality
Measured: 30 days after ECMO implantation
All-cause mortality
Measured: 12 months after ECMO implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Yong-feng Shao, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405817
- Sponsor's protocol ID
- ECLS-Jsph
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients Treated With Extracorporeal Life Support
- ClinicalTrials.gov ID
- NCT04405817
- Acronym / sponsor ID
- ECLS-Jsph
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Heart Failure, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving ECMO for circulatory and/or respiratory support
Key inclusion criteria (1 listed)
- Patients receiving ECMO for circulatory and/or respiratory support
Key exclusion criteria (1 listed)
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMOECMO for circulatory and/or respiratory support | Device | – |
Primary outcome
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Time frame: 30 days after ECMO implantation
2 secondary outcomes
All-cause mortality
Time frame: 30 days after ECMO implantation
All-cause mortality
Time frame: 12 months after ECMO implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-feng Shao study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (18801281613, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device (time frame: 30 days after ECMO implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.