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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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Medical University of Vienna
Vienna, Austria
Start Date
May 3, 2024
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2027
Last Updated
September 29, 2025
30
ESTIMATED participants
Transthoracic Echocardiography
DEVICE
Uncalibrated Pulse Contour Analysis
DEVICE
Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis
DEVICE
Esophageal Doppler
DEVICE
Bioreactance
DEVICE
Passive Leg Raising
DIAGNOSTIC_TEST
Vena Cava Ultrasound
DIAGNOSTIC_TEST
End-expiratory /-inspiratory occlusion test
DIAGNOSTIC_TEST
Fluid bolus
DRUG
Lead Sponsor
Medical University of Vienna
NCT07409727
NCT07414056
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06701669