Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06593756

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)

Led by Medical University of Vienna · Updated on 2025-09-29

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of different methods for monitoring blood circulation and predicting fluid responsiveness in patients receiving venoarterial extracorporeal membrane oxygenation (VA ECMO). VA ECMO is a treatment that supports circulation in patients with severe heart failure or cardiac arrest by oxygenating blood outside the body and returning it to the bloodstream. The study aims to validate common hemodynamic monitoring tools in this specific setting, as artificial circulation may affect measurement accuracy. Participants will undergo serial hemodynamic assessments throughout their ECMO therapy. These assessments use devices like transthoracic echocardiography, uncalibrated pulse contour analysis, transpulmonary thermodilution, bioreactance, and esophageal doppler. Fluid responsiveness will be tested using maneuvers such as passive leg raising, respiratory pulse pressure variation, stroke volume variation, inferior vena cava ultrasound, and end-inspiratory or end-expiratory occlusion tests. Fluid boluses may be given to verify responsiveness. During the study, researchers will collect repeated measurements of cardiac output, tricuspid annular plane systolic excursion, tissue doppler imaging tricuspid annular velocity, and other hemodynamic variables throughout ECMO therapy and up to seven days after ECMO removal. These data will help compare the performance of different monitoring techniques. The study duration varies per participant, ranging from a few days to up to 24 weeks of ECMO therapy, with continued monitoring after treatment ends.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient receiving VA ECMO support
  • Age 18 - 75 years
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Conditions not allowing for passive leg raising maneuvers, such as open abdomen, elevated intracranial pressure, recent leg or spinal trauma, or orthopedic issues preventing leg raising
  • Known ischemic or hemorrhagic stroke within 3 months prior to study enrollment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Throughout VA ECMO therapy (ranging from a few days up to 24 weeks)

Participants undergo serial hemodynamic assessments using various monitoring techniques such as transthoracic echocardiography, pulse contour analysis, transpulmonary thermodilution, bioreactance, and esophageal doppler. Maneuvers to assess fluid responsiveness including passive leg raising, vena cava ultrasound, and occlusion tests are performed to validate hemodynamic monitoring methods during VA ECMO therapy.

Repeated measurements throughout ECMO therapy

Fluid Responsiveness Verification

Duration - During VA ECMO therapy as needed

Participants receive a fluid bolus of 500 ml balanced crystalloids over 15-20 minutes following passive leg raising and return to baseline positioning to verify fluid responsiveness.

Fluid bolus administered during diagnostic evaluations

Follow-up Monitoring

Duration - Up to 7 days after ECMO removal

After ECMO removal, participants are monitored with repeated hemodynamic measurements to assess ongoing cardiac function and fluid responsiveness.

Repeated measurements within 7 days after ECMO removal

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

B

Bernhard Nagler, MD

T

Thomas Staudinger, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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