Hemodynamic Monitoring and Fluid Responsiveness in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) - "HemodynamECMOnitoring-VA Study"

Not Applicable

Recruiting

• Conditions: ECMO Treatment; ARDS; Pneumonia; Intensive Care; Hemodynamic Monitoring; Fluid Responsiveness
• Interventions: 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

• Registration Number: NCT06593756
• Lead Sponsor: Medical University of Vienna

Brief 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. 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 Timeline

• Study Start: 2024-05-03
• Study First Submitted: 2024-05-03
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient receiving VA ECMO support
• Age 18 - 75 years

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Entire Study Population	Transthoracic Echocardiography	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.
Entire Study Population	Uncalibrated Pulse Contour Analysis	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.
Entire Study Population	Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis	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.
Entire Study Population	Esophageal Doppler	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.
Entire Study Population	Bioreactance	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.
Entire Study Population	Passive Leg Raising	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.
Entire Study Population	Vena Cava Ultrasound	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.
Entire Study Population	Fluid bolus	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.
Entire Study Population	End-expiratory /-inspiratory occlusion test	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.

Primary Outcome Measures

Name	Time	Method
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).	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.
Changes of cardiac output (L/min) over the course of ECMO therapy	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.	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.
Changes of tricuspid annular plane systolic excursion (TAPSE, mm) over the course of ECMO therapy	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.	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.
Changes of tissue doppler imaging tricuspid annular velocity (cm/s) over the course of ECMO therapy	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.	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.
Changes in cardiac output (L/min, measured by transthoracic echocardiography, uncalibrated pulse contour analysis, thermodilution) at different ECMO blood flow rates	During the first (up to 7) days of VA ECMO therapy.	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria