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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational arm | Patients on VA-ECMO, eligible for weaning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure-volume loop measurements | Other | Pressure-volume loop measurements using a conductance catheter |
|
| 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) |
| 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 |
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Inclusion Criteria:
- On VA-ECMO support for any indication
Exclusion Criteria:
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Adult patients on VA-ECMO support for any indication
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoon JM van den Enden, MD | Contact | +31 10 7038896 | a.vandenenden@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas M Van Mieghem, Prof MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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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 |