Extracorporeal Membrane OxygenationNCT04102072
The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
A study testing Trendelenburg Maneuver and dobutamine stress test in people with Extracorporeal Membrane Oxygenation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Objective： 1. To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO 2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Trendelenburg Maneuver and dobutamine stress test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2019to Aug 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac surgery
- treatment with VA-ECMO
- mechanical ventilation
- hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)
Who cannot join
- age < 18
- cardiac arrhythmia
- moderate to severe aortic, mitral and tricuspid regurgitation
- active hemorrhage
- IABP
- spontaneous triggering of the ventilator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan university
Shanghai, 200032
Guo-wei Tu, Doctor, 86-021-64041990, tu.guowei@zs-hospital.sh.cn
About this study
Objective：
- To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO
- To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes
Read the detailed description
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Trendelenburg Maneuver, dobutamine stress test
- Keywords
- pulmonary artery catheter, echocardiography, fluid responsiveness, extracorporeal membrane oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg ManeuverDiagnostic test
In the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.
dobutamine stress testDiagnostic test
Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg Maneuver | Experimental | The Trendelenburg position is a common treatment in medicine.It is used either as a diagnostic tool to assess fluid loading response or as a therapeutic maneuver pending fluid resuscitation.With the advantage of autotransfusion readily available,the Trendelenburg position is used for expected instantaneous effect on cardiovascular performance. Receives: Diagnostic Test: Trendelenburg Maneuver |
| dobutamine stress test | Experimental | Dobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility. Receives: Diagnostic Test: dobutamine stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Cardiac Output measurement
Cardiac Output measured at baseline position（ in a supine position with the head elevated to 15° for baseline measurements ）
Measured: within1 minute at baseline position
Cardiac Output measurement afterTrendelenburg Maneuver
Cardiac Output measured after Trendelenburg Maneuver
Measured: 1 minute after starting Trendelenburg Maneuver
Cardiac Output measurement after Dobutamine stress test
Cardiac Output measured after dobutamine stress test
Measured: 5 minutes after dobutamine stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start23 Aug 2019
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, Doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102072
- Sponsor's protocol ID
- COMMENT
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 26 Sep 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 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
- ClinicalTrials.gov ID
- NCT04102072
- Acronym / sponsor ID
- COMMENT
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- pulmonary artery catheter, echocardiography, fluid responsiveness, extracorporeal membrane oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 25 Sep 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.
Objective：
- To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO
- To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes
Detailed description
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg Maneuver | Experimental | Diagnostic Test: Trendelenburg ManeuverThe Trendelenburg position is a common treatment in medicine.It is used either as a diagnostic tool to assess fluid loading response or as a therapeutic maneuver pending fluid resuscitation.With the advantage of autotransfusion readily available,the Trendelenburg position is used for expected instantaneous effect on cardiovascular performance. |
| dobutamine stress test | Experimental | Diagnostic Test: dobutamine stress testDobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cardiac surgery
- treatment with VA-ECMO
- mechanical ventilation
- hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)
Key exclusion criteria (6 listed)
- age < 18
- cardiac arrhythmia
- moderate to severe aortic, mitral and tricuspid regurgitation
- active hemorrhage
- IABP
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 |
|---|---|---|
| Trendelenburg ManeuverIn the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume. | Diagnostic test | Trendelenburg Maneuver |
| dobutamine stress testDobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded. | Diagnostic test | dobutamine stress test |
Primary outcome
Baseline Cardiac Output measurement
Time frame: within1 minute at baseline position
Cardiac Output measured at baseline position（ in a supine position with the head elevated to 15° for baseline measurements ）
Cardiac Output measurement afterTrendelenburg Maneuver
Time frame: 1 minute after starting Trendelenburg Maneuver
Cardiac Output measured after Trendelenburg Maneuver
Cardiac Output measurement after Dobutamine stress test
Time frame: 5 minutes after dobutamine stress test
Cardiac Output measured after dobutamine stress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
Zhe Luo, Doctor study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg Maneuver and dobutamine stress test in people with Extracorporeal Membrane Oxygenation, run by Shanghai Zhongshan 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 4 inclusion and 6 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 26 Sep 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 Guo-wei Tu, Doctor (86-021-64041990, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Cardiac Output measurement (time frame: within1 minute at baseline position). The study lists 3 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 26 Sep 2019.