Monitoring heart function during ECMO support
Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort I: Veno-arterial Extracorporeal Membrane Oxygenation (PLUTO-I)
This study is trying to see if measuring heart pressure and volume in real-time can help doctors better understand how to safely reduce support for patients on a heart-lung machine called VA-ECMO.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT05909280 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of cardiovascular physiology changes in patients undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) by utilizing real-time pressure-volume loop measurements. Patients on VA-ECMO who are eligible for weaning will have their biventricular pressure-volume loops measured at different levels of extracorporeal support. The goal is to identify novel predictors for successful weaning from VA-ECMO and improve decision-making regarding patient management. This approach may provide a more individualized assessment of hemodynamic profiles during treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 and older who are currently on VA-ECMO support.
Not a fit: Patients who are under 18 years old or those who have had VA-ECMO re-initiated during the same ICU admission will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved weaning strategies from VA-ECMO, enhancing patient outcomes and recovery times.
How similar studies have performed: While the use of pressure-volume loop measurements in this context is innovative, previous studies have suggested potential benefits in understanding cardiac physiology, indicating a promising but novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - On VA-ECMO support for any indication Exclusion Criteria: * Age \< 18 years * Re-initiation of VA-ECMO during the same ICU admission
Where this trial is running
Rotterdam, Zuid-Holland
- Erasmus Medical Center — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nicolas M Van Mieghem, Prof MD PhD — Erasmus Medical Center
- Study coordinator: Antoon JM van den Enden, MD
- Email: a.vandenenden@erasmusmc.nl
- Phone: +31 10 7038896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.