Clinical trial NCT05909280: 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)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Membrane Oxygenation
Cardio/Pulm: Heart Failure
Keywords: Pressure-volume loop
Cardiac mechanoenergetics
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients on VA-ECMO support for any indication

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.

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

Primary outcomes:
measure: Stroke Work in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Potential Energy in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Pressure-Volume Area in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Secondary outcomes:
measure: Stroke Volume in mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Cardiac Output
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Preload recruitable stroke work in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Tau in ms
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Systolic and diastolic intraventricular dyssynchrony in %
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Minimal and maximal dP/dt in mmHg/s
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Arterial elastance (Ea) and end-systolic elastance (Ees) in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: End-diastolic and end-systolic pressure in mmHg
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: End-diastolic and end-systolic volume in mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: Starling Contractile Index in mmHg/mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: V0, V15, V30 and V100 in mL
timeFrame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
measure: All-cause mortality
timeFrame: Within 30 days after study measurements
measure: Successful weaning from VA-ECMO
timeFrame: 48 hours after study measurements
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas M Van Mieghem, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: