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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational arm Patients on VA-ECMO, eligible for weaning |
Other: Pressure-volume loop measurements
Pressure-volume loop measurements using a conductance catheter
|
Outcome Measures
Primary Outcome Measures
- Stroke Work in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
The energy necessary for the myocardium to propel blood in the ventricle. Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Potential Energy in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
The (unused) energy stored in the myocardium following systole. Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Pressure-Volume Area in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
The net metabolic demand of the myocardium throughout the cardiac cycle. Expressed by PV-loop reconstructions based on conductance catheter measurements.
Secondary Outcome Measures
- Stroke Volume in mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Cardiac Output [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
By thermodilution, using pulmonary artery catheterization
- Preload recruitable stroke work in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Tau in ms [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Systolic and diastolic intraventricular dyssynchrony in % [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Minimal and maximal dP/dt in mmHg/s [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Arterial elastance (Ea) and end-systolic elastance (Ees) in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements (following application of concerning single-beat algorithms)
- End-diastolic and end-systolic pressure in mmHg [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- End-diastolic and end-systolic volume in mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- Starling Contractile Index in mmHg/mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
Expressed by PV-loop reconstructions based on conductance catheter measurements.
- V0, V15, V30 and V100 in mL [Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)]
I.e. ventricular volume at 0, 15, 30 and 100 mmHg, expressed by PV-loop reconstructions based on conductance catheter measurements.
- All-cause mortality [Within 30 days after study measurements]
Mortality, irrespective of etiology
- Successful weaning from VA-ECMO [48 hours after study measurements]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus Medical Center | Rotterdam | Zuid-Holland | Netherlands | 3015GD |
Sponsors and Collaborators
- Erasmus Medical Center
Investigators
- Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLUTO-I