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.

Recruiting

• Conditions: multi-orgaanfalen; Combined refractory respiratory and hemodynamic failure; organ failure; 10019280

• Registration Number: NL-OMON51884
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

On VA-ECMO support for any indication. According to our centre*s protocol,
indications for VA-ECMO initiation are hemodynamic and/or respiratory failure,
cardiogenic shock, (accidental) hypothermia, ECPR, bridge to cardiac assist
device implant and bridge to heart (and/or lung) transplant.

In short, all patients on VA-ECMO support are eligible for study participation,
irrespective of their clinical indication for VA-ECMO initiation. We foresee
study results will not be influenced by patient selection, since study
inclusion criteria do not comprise any clinical conditions.

Exclusion Criteria

- Age < 18 years.
- Re-initiation of VA-ECMO during the same ICU admission.

In conclusion, all patients with established VA-ECMO support are eligible for
study participation: clinical grounds and conditions are irrelevant for study
inclusion, given the study*s objective of identifying changes in baseline
physiology induced by VA-ECMO support.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints are the biventricular pressure volume loop<br /><br>characteristics reflecting cardiac mechanoenergetics, including stroke work and<br /><br>potential energy (together extrapolated into the pressure volume area) compared<br /><br>between 4.0-3.0-2.0-1.0-0.5 L/min VA-ECMO blood flow in individual patients.<br /><br><br /><br>Regarding the substudy: The difference in LV preload in individual VA-ECMO<br /><br>patients, reflected by the LV PVL derived parameter End-Diastolic Volume (EDV<br /><br>in mL). this parameter will be measured at 100% VA-ECMO blood flow for each<br /><br>PEEP level (i.e. 20, 10 and 0 cmH20). </p><br>