ECMO TreatmentNCT06593756
Hemodynamic Monitoring and Fluid Responsiveness in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) - "HemodynamECMOnitoring-VA Study"
A study testing Transthoracic Echocardiography, Uncalibrated Pulse Contour Analysis and Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis in people with ECMO Treatment and ARDS, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ECMO Treatment, ARDS, Pneumonia
- What is being tested?
- Transthoracic Echocardiography, Uncalibrated Pulse Contour Analysis and Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 3 May 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient receiving VA ECMO support
- Age 18 - 75 years
Who cannot join
- Pregnancy
- Conditions not allowing for passive leg raising maneuvers, e.g. "open abdomen", known or suspected elevation of intracranial pressure, recent leg or spinal trauma or orthopedic conditions not permitting leg raising
- Known ischemic or hemorrhagic stroke within 3 months prior to study enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Thomas Staudinger, MD, +4314040044920, thomas.staudinger@meduniwien.ac.at
Bernhard Nagler, MD, +4314040044920, bernhard.nagler@meduniwien.ac.at
About this study
Official title: Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation - A Prospective Diagnostic Accuracy Study ("HemodynamECMOnitoring-VA Study")
In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Continuous monitoring of cardiac function and circulatory status (blood pressure, blood flow to organs) is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions. Various devices are routinely used for this task. However, in the specific situation of ECMO treatment, the measurements of these devices could be affected due to the artificial circulation; outside the body. The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment.
Read the detailed description
Hemodynamic monitoring and tests for fluid responsiveness are cornerstones of intensive care medicine. Generally, hemodynamic measurements can be obtained, for instance, with the following methods: pulmonary artery catheter, transthoracic echocardiography (TTE), esophageal doppler, transpulmonary thermodilution, pulse contour analysis and bioreactance, amongst others. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests. While these commonly used methods of hemodynamic assessment have been validated in various clinical scenarios, data are lacking in the setting of venoarterial extracorporeal membrane oxygenation (VA ECMO). VA ECMO is commonly used for circulatory support in patients with severe hemodynamic failure or cardiac arrest. Blood is most commonly drained from a femoral vein, pumped through an oxygenator, where it is oxygenated and decarboxylated, and thereafter reinfused into the patient via an arterial, most commonly femoral, return cannula. Theoretically, the artificial circulation with its blood drainage and return flows may interfere with common hemodynamic monitoring techniques and lead to erroneous measurements. The aim of this study therefore is to validate select techniques of hemodynamic monitoring and assessment of fluid responsiveness in patients on VA ECMO. In the context of this study, the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared.
- Conditions
- ECMO Treatment, ARDS, Pneumonia, Intensive Care, Hemodynamic Monitoring, Fluid Responsiveness
- Being tested
- Transthoracic Echocardiography, Uncalibrated Pulse Contour Analysis, Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis, Esophageal Doppler, Bioreactance
- Keywords
- VV ECMO, Extracorporeal Membrane Oxygenation, ARDS, Intensive Care Medicine, Critical Care Medicine, Hemodynamic Monitoring, Fluid Responsiveness, Passive Leg Raising, Pulse Contour Analysis, Transpulmonary Thermodilution, Bioreactance, Pulse Pressure Variation, End-expiratory Occlusion Test, End-inspiratory Occlusion Test, Cardiac Output, LVOT VTI, Stroke Volume, Vena Cava Ultrasound
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDevice
Transthoracic echocardiography (TTE) is used for intermittent non-invasive stroke volume (SV) measurements. It is calculated by multiplication of left ventricular out flow tract (LVOT) and LVOT velocity time integral (VTI), obtained in a parasternal long axis view and apical five chamber view, respectively.
Uncalibrated Pulse Contour AnalysisDevice
Pulse Contour Analysis allows an automated and continuous measurement of stroke volume (SV). Its underlying principle is that the integral of the systolic arterial pressure curve directly correlates with stroke volume.
Transpulmonary Thermodilution/Calibrated Pulse Contour AnalysisDevice
Transpulmonary thermodilution (TPTD) involves the administration of a cold saline bolus into a central venous catheter. A special thermistor catheter placed in the femoral or brachial artery detects the successive changes in blood temperature. The resulting heat dissipation curve is analyzed to estimate stroke volume, cardiac output and other hemodynamic variables such as intrathoracic thermal volume (ITTV), pulmonary thermal volume (PTV), global end-diastolic volume (GEDV), intrathoracic blood volume (ITBV) and extravascular lung water (EVLW). Intermittent TPTD-derived cardiac output measurements (typically performed 1-3x/d) are used to calibrate pulse contour analysis.
Esophageal DopplerDevice
In esophageal Doppler, a thin ultrasound probe, coated with aqueous ultrasound gel, is orally or nasally inserted into the esophagus and orientated towards the aorta. By emission and detection of continuous wave Doppler signals, real time spectral waveforms of red blood cell velocity in the aorta are obtained, from which cardiac indices can be derived.
BioreactanceDevice
Bioreactance is a noninvasive hemodynamic monitoring technique, in which four double electrode sensors are placed on the skin of the chest. A high frequency sine wave is transmitted across the thorax. Pulsatile flow in the aorta causes phase shifts and amplitude changes of this signal, which are measured across the different electrodes and used to compute cardiac output.
Passive Leg RaisingDiagnostic test
Passive Leg Raising (PLR) is a maneuver that mimics a fluid challenge by shifting about 300 ml of venous blood from the lower body to the heart. Thereby, it can help to predict fluid responsiveness without actual fluid infusion. To start with, the patient is placed in a semi-recumbent position. Then, the bed is adjusted so that the patient's torso is moved to a horizontal position and the lower limbs are raised to an angle of 45°. Hemodynamic effects occur and can be measured within one minute.
Vena Cava UltrasoundDiagnostic test
Inferior Vena Cava (IVC) Ultrasound has become a popular technique for assessing volume status. IVC diameter is measured in a subcostal long-axis IVC view 1-2 cm from the junction with the right atrium. The magnitude of distensibility during mechanical ventilation cycles or collapsibility during spontaneous breathing has been proposed to correlate with fluid responsiveness
End-expiratory /-inspiratory occlusion testDiagnostic test
In preload-dependent patients, mechanical ventilation induces periodic changes in cardiac output. Standardized maneuvers of end-expiratory or end-inspiratory interruption over 15 seconds may increase or decrease stroke volume, respectively, which is a valid predictor of fluid responsiveness
Fluid bolusDrug
To verify fluid responsiveness, 500 ml of balanced crystalloids will be infused over a time of 15-20 min (25-33.33 ml/min) after completion of passive leg raising and restoration of baseline patient positioning
| Study group | Role | What they receive |
|---|---|---|
| Entire Study Population | Experimental | The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests. Receives: Device: Transthoracic Echocardiography; Device: Uncalibrated Pulse Contour Analysis; Device: Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis; Device: Esophageal Doppler; Device: Bioreactance; Diagnostic Test: Passive Leg Raising; Diagnostic Test: Vena Cava Ultrasound; Diagnostic Test: End-expiratory /-inspiratory occlusion test; Drug: Fluid bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of receiver operating characteristic (ROC) curves for predicting fluid responsiveness using the passive leg-raising test between different cardiac output measurement techniques (echocardiography, pulse contour analysis, thermodilution).
Cardiac Output (L/min) will be measured using transthoracic echocardiography, uncalibrated pulse contour analysis, and thermodilution before, during, and after a passive leg-raising test, as well as after administration of a fluid bolus of 500 ml balanced crystalloids over 15-20 min. A cardiac output increase of > 15% will be the cut-off for defining fluid responsiveness. Receiver operating characteristic (ROC) curves will be generated for each cardiac output measurement technique and compared using the Hanley-McNeil method. The agreement between the ROC curves (Hanley-McNeil test statistic) will serve as the primary outcome.
Measured: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.
Secondary outcomes (5)
Diagnostic performance (receiver operating characteristic (ROC) area under the curve) of an inspiratory and expiratory occlusion test in conjunction with pulse contour analysis for the prediction of fluid responsiveness during ECMO.
Cardiac Output (L/min) will be measured using calibrated and uncalibrated pulse contour analysis before, during, and after an end-inspiratory and end-expiratory occlusion test (15 s), as well as after administration of a fluid bolus of 500 ml balanced crystalloids over 15-20 min. A cardiac output increase of > 15% after fluid infusion will be the cut-off for defining fluid responsiveness. Receiver operating characteristic (ROC) curves will be generated to assess the performance of the end-inspiratory and end-expiratory occlusion tests and the best threshold for predicting fluid responsiveness during ECMO.
Measured: Repeated measurements throughout ECMO therapy (duration ranging from a few days to several weeks) and within a few days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.
Changes of cardiac output (L/min) over the course of ECMO therapy
Cardiac output (L/min) will be measured at different time points (at least at the beginning of ECMO therapy and after ECMO removal) throughout ECMO therapy using transthoracic echocardiography, uncalibrated pulse contour analysis, and thermodilution.
Measured: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes of tricuspid annular plane systolic excursion (TAPSE, mm) over the course of ECMO therapy
Tricuspid annular plane systolic excursion (TAPSE, mm) will be measured at different time points (at least at the beginning of ECMO therapy and after ECMO removal) throughout ECMO therapy using transthoracic echocardiography.
Measured: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes of tissue doppler imaging tricuspid annular velocity (cm/s) over the course of ECMO therapy
Tissue doppler imaging tricuspid annular velocity (cm/s) will be measured at different time points (at least at the beginning of ECMO therapy and after ECMO removal) throughout ECMO therapy using transthoracic echocardiography.
Measured: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes in cardiac output (L/min, measured by transthoracic echocardiography, uncalibrated pulse contour analysis, thermodilution) at different ECMO blood flow rates
During the first days of VA ECMO therapy, cardiac output (L/min) will be measured repeatedly at different ECMO blood flow rates (baseline blood flow, blood flow reduced by 1 l/min, return to baseline blood flow, blood flow increased by 1 l/min) using transthoracic echocardiography, uncalibrated pulse contour analysis, and thermodilution.
Measured: During the first (up to 7) days of VA ECMO therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 May 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMO TreatmentStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Staudinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593756
- Sponsor's protocol ID
- 1613/2023
- Status last verified
- Sep 2025
- First submitted
- 3 May 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication may be provided to qualified researchers with academic interest in hemodynamic monitoring. Data or samples shared will be coded, with no PHI included.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation - A Prospective Diagnostic Accuracy Study ("HemodynamECMOnitoring-VA Study")
- ClinicalTrials.gov ID
- NCT06593756
- Acronym / sponsor ID
- 1613/2023
- Conditions
- ECMO Treatment, ARDS, Pneumonia, Intensive Care, Hemodynamic Monitoring, Fluid Responsiveness
- Keywords
- VV ECMO, Extracorporeal Membrane Oxygenation, ARDS, Intensive Care Medicine, Critical Care Medicine, Hemodynamic Monitoring, Fluid Responsiveness, Passive Leg Raising
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Continuous monitoring of cardiac function and circulatory status (blood pressure, blood flow to organs) is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions. Various devices are routinely used for this task. However, in the specific situation of ECMO treatment, the measurements of these devices could be affected due to the artificial circulation; outside the body. The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment.
Detailed description
Hemodynamic monitoring and tests for fluid responsiveness are cornerstones of intensive care medicine. Generally, hemodynamic measurements can be obtained, for instance, with the following methods: pulmonary artery catheter, transthoracic echocardiography (TTE), esophageal doppler, transpulmonary thermodilution, pulse contour analysis and bioreactance, amongst others. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests. While these commonly used methods of hemodynamic assessment have been validated in various clinical scenarios, data are lacking in the setting of venoarterial extracorporeal membrane oxygenation (VA ECMO). VA ECMO is commonly used for circulatory support in patients with severe hemodynamic failure or cardiac arrest. Blood is most commonly drained from a femoral vein, pumped through an oxygenator, where it is oxygenated and decarboxylated, and thereafter reinfused into the patient via an arterial, most commonly femoral, return cannula. Theoretically, the artificial circulation with its blood drainage and return flows may interfere with common hemodynamic monitoring techniques and lead to erroneous measurements. The aim of this study therefore is to validate select techniques of hemodynamic monitoring and assessment of fluid responsiveness in patients on VA ECMO. In the context of this study, the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire Study Population | Experimental | Device: Transthoracic Echocardiography, Device: Uncalibrated Pulse Contour Analysis, Device: Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis, Device: Esophageal Doppler, Device: Bioreactance, Diagnostic Test: Passive Leg Raising, Diagnostic Test: Vena Cava Ultrasound, Diagnostic Test: End-expiratory /-inspiratory occlusion test, Drug: Fluid bolusThe entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient receiving VA ECMO support
- Age 18 - 75 years
Key exclusion criteria (3 listed)
- Pregnancy
- Conditions not allowing for passive leg raising maneuvers, e.g. "open abdomen", known or suspected elevation of intracranial pressure, recent leg or spinal trauma or orthopedic conditions not permitting leg raising
- Known ischemic or hemorrhagic stroke within 3 months prior to study enrollment.
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 |
|---|---|---|
| Transthoracic EchocardiographyTransthoracic echocardiography (TTE) is used for intermittent non-invasive stroke volume (SV) measurements. It is calculated by multiplication of left ventricular out flow tract (LVOT) and LVOT velocity time integral (VTI), obtained in a parasternal long axis view and apical five chamber view, respectively. | Device | Entire Study Population |
| Uncalibrated Pulse Contour AnalysisPulse Contour Analysis allows an automated and continuous measurement of stroke volume (SV). Its underlying principle is that the integral of the systolic arterial pressure curve directly correlates with stroke volume. | Device | Entire Study Population |
| Transpulmonary Thermodilution/Calibrated Pulse Contour AnalysisTranspulmonary thermodilution (TPTD) involves the administration of a cold saline bolus into a central venous catheter. A special thermistor catheter placed in the femoral or brachial artery detects the successive changes in blood temperature. The resulting heat dissipation curve is analyzed to estimate stroke volume, cardiac output and other hemodynamic variables such as intrathoracic thermal volume (ITTV), pulmonary thermal volume (PTV), global end-diastolic volume (GEDV), intrathoracic blood volume (ITBV) and extravascular lung water (EVLW). Intermittent TPTD-derived cardiac output measurements (typically performed 1-3x/d) are used to calibrate pulse contour analysis. | Device | Entire Study Population |
| Esophageal DopplerIn esophageal Doppler, a thin ultrasound probe, coated with aqueous ultrasound gel, is orally or nasally inserted into the esophagus and orientated towards the aorta. By emission and detection of continuous wave Doppler signals, real time spectral waveforms of red blood cell velocity in the aorta are obtained, from which cardiac indices can be derived. | Device | Entire Study Population |
| BioreactanceBioreactance is a noninvasive hemodynamic monitoring technique, in which four double electrode sensors are placed on the skin of the chest. A high frequency sine wave is transmitted across the thorax. Pulsatile flow in the aorta causes phase shifts and amplitude changes of this signal, which are measured across the different electrodes and used to compute cardiac output. | Device | Entire Study Population |
| Passive Leg RaisingPassive Leg Raising (PLR) is a maneuver that mimics a fluid challenge by shifting about 300 ml of venous blood from the lower body to the heart. Thereby, it can help to predict fluid responsiveness without actual fluid infusion. To start with, the patient is placed in a semi-recumbent position. Then, the bed is adjusted so that the patient's torso is moved to a horizontal position and the lower limbs are raised to an angle of 45°. Hemodynamic effects occur and can be measured within one minute. | Diagnostic test | Entire Study Population |
| Vena Cava UltrasoundInferior Vena Cava (IVC) Ultrasound has become a popular technique for assessing volume status. IVC diameter is measured in a subcostal long-axis IVC view 1-2 cm from the junction with the right atrium. The magnitude of distensibility during mechanical ventilation cycles or collapsibility during spontaneous breathing has been proposed to correlate with fluid responsiveness | Diagnostic test | Entire Study Population |
| End-expiratory /-inspiratory occlusion testIn preload-dependent patients, mechanical ventilation induces periodic changes in cardiac output. Standardized maneuvers of end-expiratory or end-inspiratory interruption over 15 seconds may increase or decrease stroke volume, respectively, which is a valid predictor of fluid responsiveness | Diagnostic test | Entire Study Population |
| Fluid bolusTo verify fluid responsiveness, 500 ml of balanced crystalloids will be infused over a time of 15-20 min (25-33.33 ml/min) after completion of passive leg raising and restoration of baseline patient positioning | Drug | Entire Study Population |
Primary outcome
Agreement of receiver operating characteristic (ROC) curves for predicting fluid responsiveness using the passive leg-raising test between different cardiac output measurement techniques (echocardiography, pulse contour analysis, thermodilution).
Time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.
Cardiac Output (L/min) will be measured using transthoracic echocardiography, uncalibrated pulse contour analysis, and thermodilution before, during, and after a passive leg-raising test, as well as after administration of a fluid bolus of 500 ml balanced crystalloids over 15-20 min. A cardiac output increase of > 15% will be the cut-off for defining fluid responsiveness. Receiver operating characteristic (ROC) curves will be generated for each cardiac output measurement technique and compared using the Hanley-McNeil method. The agreement between the ROC curves (Hanley-McNeil test statistic) will serve as the primary outcome.
5 secondary outcomes
Diagnostic performance (receiver operating characteristic (ROC) area under the curve) of an inspiratory and expiratory occlusion test in conjunction with pulse contour analysis for the prediction of fluid responsiveness during ECMO.
Time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to several weeks) and within a few days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.
Changes of cardiac output (L/min) over the course of ECMO therapy
Time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes of tricuspid annular plane systolic excursion (TAPSE, mm) over the course of ECMO therapy
Time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes of tissue doppler imaging tricuspid annular velocity (cm/s) over the course of ECMO therapy
Time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.
Changes in cardiac output (L/min, measured by transthoracic echocardiography, uncalibrated pulse contour analysis, thermodilution) at different ECMO blood flow rates
Time frame: During the first (up to 7) days of VA ECMO therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication may be provided to qualified researchers with academic interest in hemodynamic monitoring. Data or samples shared will be coded, with no PHI included.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Echocardiography, Uncalibrated Pulse Contour Analysis and Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis in people with ECMO Treatment and ARDS, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Nagler, MD (+4314040044920, bernhard.nagler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of receiver operating characteristic (ROC) curves for predicting fluid responsiveness using the passive leg-raising test between different cardiac output measurement techniques (echocardiography, pulse contour analysis, thermodilution). (time frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.). 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 29 Sep 2025.