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)

Extracorporeal Membrane Oxygenation Clinical Trial

— PLUTO-I  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909280
• Other study ID #: PLUTO-I
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: December 14, 2024

Study information

• Verified date: January 2024
• Source: Erasmus Medical Center
• Contact: Antoon JM van den Enden, MD
• Phone: +31 10 7038896
• Email: a.vandenenden[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 14, 2024
• Est. primary completion date: November 14, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• On VA-ECMO support for any indication

Exclusion Criteria:

• Age < 18 years

• Re-initiation of VA-ECMO during the same ICU admission

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation
• Heart Failure

Intervention

Other:
• Pressure-volume loop measurements
Pressure-volume loop measurements using a conductance catheter

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Cardiac Output	By thermodilution, using pulmonary artery catheterization	Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	All-cause mortality	Mortality, irrespective of etiology	Within 30 days after study measurements
Secondary	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