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)

NCT05909280 | Unknown

• 1 other identifier: PLUTO-I
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation; Cardio/Pulm: Heart Failure

Keywords

Pressure-volume loop; Cardiac mechanoenergetics

Outcome Measures

Primary Outcomes (3)

• Stroke Work in mmHg/mL

  The energy necessary for the myocardium to propel blood in the ventricle. Expressed by PV-loop reconstructions based on conductance catheter measurements.

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Potential Energy in mmHg/mL

  The (unused) energy stored in the myocardium following systole. Expressed by PV-loop reconstructions based on conductance catheter measurements.

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Pressure-Volume Area in mmHg/mL

  The net metabolic demand of the myocardium throughout the cardiac cycle. Expressed by PV-loop reconstructions based on conductance catheter measurements.

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

Secondary Outcomes (13)

• Stroke Volume in mL

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Cardiac Output

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Preload recruitable stroke work in mmHg/mL

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Tau in ms

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

• Systolic and diastolic intraventricular dyssynchrony in %

  Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

Study Arms (1)

Observational arm

Patients on VA-ECMO, eligible for weaning

Other: Pressure-volume loop measurements

Interventions

Pressure-volume loop measurements OTHER

Pressure-volume loop measurements using a conductance catheter

Observational arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients on VA-ECMO support for any indication

You may qualify if:

• \- On VA-ECMO support for any indication

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Study Officials

• Nicolas M Van Mieghem, Prof MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoon JM van den Enden, MD

CONTACT

+31 10 7038896; a.vandenenden@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Cardiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: June 18, 2023
• Study Start: November 14, 2022
• Primary Completion: November 14, 2024
• Study Completion: December 14, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)