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) (PLUTO-I)

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Cardio/Pulm: Heart Failure
• Intervention / Treatment: Other: Pressure-volume loop measurements

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Antoon JM van den Enden, MD; Phone Number: +31 10 7038896; Email: a.vandenenden@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Antoon JM van den Enden, MD; Phone Number: +31 70 308896; Email: a.vandenenden@erasmusmc.nl
      • Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Adult patients on VA-ECMO support for any indication

Description

Inclusion Criteria:

- On VA-ECMO support for any indication

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational arm; Patients on VA-ECMO, eligible for weaning	Other: Pressure-volume loop measurements; Pressure-volume loop measurements using a conductance catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Volume in mL	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Cardiac Output	By thermodilution, using pulmonary artery catheterization	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Preload recruitable stroke work in mmHg/mL	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Tau in ms	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Systolic and diastolic intraventricular dyssynchrony in %	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Minimal and maximal dP/dt in mmHg/s	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Arterial elastance (Ea) and end-systolic elastance (Ees) in mmHg/mL	Expressed by PV-loop reconstructions based on conductance catheter measurements (following application of concerning single-beat algorithms)	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
End-diastolic and end-systolic pressure in mmHg	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
End-diastolic and end-systolic volume in mL	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Starling Contractile Index in mmHg/mL	Expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
V0, V15, V30 and V100 in mL	I.e. ventricular volume at 0, 15, 30 and 100 mmHg, expressed by PV-loop reconstructions based on conductance catheter measurements.	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
All-cause mortality	Mortality, irrespective of etiology	Within 30 days after study measurements
Successful weaning from VA-ECMO	A state of persistent hemodynamic stability without the necessity for re-initiation of VA-ECMO support within 48 hours after termination of VA-ECMO support as well as survival at least 48 hours after decannulation	48 hours after study measurements

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): November 14, 2024
• Study Completion (Estimated): December 14, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pressure-volume loop; Cardiac mechanoenergetics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PLUTO-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No