Shock, CardiogenicRECOVERYNCT05669183
Hemodynamic Comparison of Peripheral and Central VA ECMO.
An observational study of Shock, Cardiogenic and Cardiac Arrest, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is: Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Circulation; Complications
- What is being tested?
- Veno-arterial extracorporeal membrane oxygenation
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2023to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants require VA ECMO support for cardiogenic shock or cardiac arrest.
Who may be able to join
- Age≥18 years
- Participants with cardiogenic shock
- Obtaining informed consent from participants or their affiliated beneficiaries
Who cannot join
- Irreversible heart failure
- Contraindications to anticoagulation therapy
- Uncontrolled bleeding
- Irreversible neurological pathology
- Participants limited to extracorporeal cardiopulmonary resuscitation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yang Yan, 0086-18991232621, yangyan3@xjtu.edu.cn
Fengwei Guo, 0086-13991259800, guofengwei@xjtu.edu.cn
About this study
Official title: Comparison of Peripheral and Central Intubation on Hemodynamics in Veno-arterial-extracorporeal Membrane Oxygenation (RECOVERY): a National, Multi-center, Prospective, Cohort Study
The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is:
- Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion.
Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation.
Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.
- Conditions
- Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Circulation; Complications, Hemodynamics Instability
- Being tested
- Veno-arterial extracorporeal membrane oxygenation
- 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.
Veno-arterial extracorporeal membrane oxygenationProcedure or surgery
Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral VA ECMO | Femoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) Receives: Procedure: Veno-arterial extracorporeal membrane oxygenation | |
| Central VA ECMO | Axillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) Receives: Procedure: Veno-arterial extracorporeal membrane oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation-no. (%)
Blood gas analysis
Measured: Through VA ECMO support completion, an average of 1 week
Left ventricular end-diastolic volume (ml)
echocardiography
Measured: Through VA ECMO support completion, an average of 1 week
Left ventricular End-systolic volume (ml)
echocardiography
Measured: Through VA ECMO support completion, an average of 1 week
Stroke volume (ml)
echocardiography
Measured: Through VA ECMO support completion, an average of 1 week
Mitral valve area(cm2)
echocardiography
Measured: Through VA ECMO support completion, an average of 1 week
Secondary outcomes (5)
Rate of successful weaning from VA ECMO
Weaning success is defined as survival after complete removal of the extracorporeal circuit without requirement for further mechanical support or heart transplant.
Measured: Through study completion, up to 2 years
VA ECMO duration
Length of VA ECMO support
Measured: Through VA ECMO support, an average of 1 week
Cannulation-related complications
Cannulation-related complications include bleeding, limb ischemia, revision of cannulation site, wound complications. Limb ischemia is defined as ischemia requiring any surgical procedure, including revision of the arterial/distal perfusion cannula, fasciotomy for compartment syndrome, gangrene, or amputation. Wound complication is defined as infection or requirement of an additional surgical intervention, such as arterial repair, washout with or without vacuum-assisted closure, and muscle flap closure.
Measured: Through study completion, up to 2 years
Duration of ICU stay
Intensive care unit length of stay
Measured: Through study completion, up to 2 years
Duration of hospital stay
Length of hospital stay
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start12 Aug 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, CardiogenicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, Guangdong Provincial People's Hospital, Shaanxi Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Study director, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669183
- Sponsor's protocol ID
- XJTU1AF2021CRF-005
- Acronym
- RECOVERY
- Status last verified
- Apr 2024
- First submitted
- 30 Oct 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peripheral and Central Intubation on Hemodynamics in Veno-arterial-extracorporeal Membrane Oxygenation (RECOVERY): a National, Multi-center, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT05669183
- Acronym / sponsor ID
- RECOVERY / XJTU1AF2021CRF-005
- Conditions
- Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Circulation; Complications, Hemodynamics Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, Guangdong Provincial People's Hospital, Shaanxi Provincial Center for Disease Control and Prevention
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Dec 2022 (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.
The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is:
- Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion.
Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation.
Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral VA ECMO | – | Procedure: Veno-arterial extracorporeal membrane oxygenationFemoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) |
| Central VA ECMO | – | Procedure: Veno-arterial extracorporeal membrane oxygenationAxillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants require VA ECMO support for cardiogenic shock or cardiac arrest.
Key inclusion criteria (3 listed)
- Age≥18 years
- Participants with cardiogenic shock
- Obtaining informed consent from participants or their affiliated beneficiaries
Key exclusion criteria (5 listed)
- Irreversible heart failure
- Contraindications to anticoagulation therapy
- Uncontrolled bleeding
- Irreversible neurological pathology
- Participants limited to extracorporeal cardiopulmonary resuscitation
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 |
|---|---|---|
| Veno-arterial extracorporeal membrane oxygenationVeno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO. | Procedure or surgery | Central VA ECMO, Peripheral VA ECMO |
Primary outcome
Oxygen saturation-no. (%)
Time frame: Through VA ECMO support completion, an average of 1 week
Blood gas analysis
Left ventricular end-diastolic volume (ml)
Time frame: Through VA ECMO support completion, an average of 1 week
echocardiography
Left ventricular End-systolic volume (ml)
Time frame: Through VA ECMO support completion, an average of 1 week
echocardiography
Stroke volume (ml)
Time frame: Through VA ECMO support completion, an average of 1 week
echocardiography
Mitral valve area(cm2)
Time frame: Through VA ECMO support completion, an average of 1 week
echocardiography
5 secondary outcomes
Rate of successful weaning from VA ECMO
Time frame: Through study completion, up to 2 years
VA ECMO duration
Time frame: Through VA ECMO support, an average of 1 week
Cannulation-related complications
Time frame: Through study completion, up to 2 years
Duration of ICU stay
Time frame: Through study completion, up to 2 years
Duration of hospital stay
Time frame: Through study completion, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Shock, Cardiogenic
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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.
Yang Yan study director
First Affiliated Hospital of Xian Jiaotong 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 Shock, Cardiogenic and Cardiac Arrest, run by First Affiliated Hospital Xi'an Jiaotong 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 3 inclusion and 5 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 4 Apr 2024. 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 Yang Yan (0086-18991232621, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation-no. (%) (time frame: Through VA ECMO support completion, an average of 1 week). The study lists 5 primary outcomes in all. 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 4 Apr 2024.