Cardiogenic ShockNCT04039594
Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiogenic Shock, Cardiac Arrest
- What is being tested?
- VA ECMO
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Jul 2025
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving VA ECMO for cardiopulmonary support
Who may be able to join
- Patients receiving VA ECMO for cardiopulmonary support
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Xiaotong Hou, MD., PhD., 8610 64456631, xt.hou@ccmu.edu.cn
Xiaotong Hou, MD., PhD.
About this study
Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.
- Conditions
- Cardiogenic Shock, Cardiac Arrest
- Being tested
- VA ECMO
- Keywords
- extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest
- Medical subject headings
- Shock, Cardiogenic, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA ECMODevice
VA ECMO for cardiopulmonary support
| Study group | Role | What they receive |
|---|---|---|
| ECMO | Not described Receives: Device: VA ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days
Secondary outcomes (5)
All-cause mortality
Measured: 365 days
Rate of successful weaning from ECMO
Measured: 30 days
ECMO-related complications
Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change
Measured: 30 days
Other complications
Acute renal failure, ulcer bleeding, pneumonia, sepsis
Measured: 30 days
Duration stay at ICU and hospital
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 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 Beijing Anzhen HospitalThe 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039594
- Sponsor's protocol ID
- 2019027X
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04039594
- Acronym / sponsor ID
- 2019027X
- Conditions
- Cardiogenic Shock, Cardiac Arrest
- Keywords
- extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 31 Jul 2019 (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.
Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | Device: VA ECMO |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving VA ECMO for cardiopulmonary support
Key inclusion criteria (1 listed)
- Patients receiving VA ECMO for cardiopulmonary 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 |
|---|---|---|
| VA ECMOVA ECMO for cardiopulmonary support | Device | ECMO |
Primary outcome
All-cause mortality
Time frame: 30 days
5 secondary outcomes
All-cause mortality
Time frame: 365 days
Rate of successful weaning from ECMO
Time frame: 30 days
ECMO-related complications
Time frame: 30 days
Other complications
Time frame: 30 days
Duration stay at ICU and hospital
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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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.
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 Beijing Anzhen Hospital 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 6 Aug 2019. 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 Xiaotong Hou, MD., PhD. (8610 64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). 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 6 Aug 2019.