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)

NCT ID: NCT05909280

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2024-12-14

Brief Summary

Invasive pressure-volume (PV) loop measurements have the potential to confirm or refute earlier computer simulations and animal studies regarding changes in cardiovascular physiology induced by (veno-arterial) ECMO. PV loop analysis could create a framework for the (ICU-) clinician for VA-ECMO weaning guidance, based on a patient's individual hemodynamic profile. PV loop measurements may, in future, serve as a guide for which patient would benefit most from (prolonged) VA-ECMO support or which patient would require additional LV unloading. Within the context of PLUTO-I, patients on VA-ECMO support who are eligible for weaning from VA-ECMO will undergo biventricular PV loop measurements on different intensities of extracorporeal support.

Detailed Description

Using VA-ECMO support, physiological stability can be maintained in patients with refractory hemodynamic failure as bridge to recovery, definitive therapy or decision making. Previous animal studies and computer simulations hypothesize increased LV afterload as well as RV distention during VA-ECMO. Decision making concerning VA-ECMO weaning is largely based on bedside hemodynamic (including echocardiographic) parameters. Profound details of the effects of VA-ECMO on elemental cardiac physiology, including myocardial metabolic efficiency and ventricular-arterial coupling, are limited. We hypothesize biventricular pressure-volume loop (PVL) measurement will enhance understanding of elemental cardiovascular physiology including ventricular interdependence during different levels of VA-ECMO support. PVL measurement will hypothetically provide opportunities in discovering novel predictors for successful weaning from VA-ECMO support. For the purpose of PLUTO-I, patients on VA-ECMO who are eligible to wean will undergo invasive PV-loop measurements on different intensities of extracorporeal flow.

Conditions

Extracorporeal Membrane Oxygenation; Cardio/Pulm: Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational arm

Patients on VA-ECMO, eligible for weaning

Pressure-volume loop measurements

Intervention Type: OTHER

Pressure-volume loop measurements using a conductance catheter

Interventions

Pressure-volume loop measurements

Pressure-volume loop measurements using a conductance catheter

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nicolas van Mieghem

Head of Interventional Cardiology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas M Van Mieghem, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Antoon JM van den Enden, MD

Role: CONTACT

a.vandenenden@erasmusmc.nl

+31 10 7038896

Facility Contacts

Antoon JM van den Enden, MD

Role: primary

a.vandenenden@erasmusmc.nl

+31 70 308896

Other Identifiers

PLUTO-I

Identifier Type: -

Identifier Source: org_study_id