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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pressure-Volume Area in mmHg/mL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On VA-ECMO support for any indication
排除标准
- •Age < 18 years
- •Re-initiation of VA-ECMO during the same ICU admission
结局指标
主要结局
Pressure-Volume Area in mmHg/mL
时间窗: 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.
Stroke Work in mmHg/mL
时间窗: 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
时间窗: 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.
次要结局
- Stroke Volume in mL(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- Preload recruitable stroke work in mmHg/mL(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- V0, V15, V30 and V100 in mL(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- All-cause mortality(Within 30 days after study measurements)
- Cardiac Output(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- Systolic and diastolic intraventricular dyssynchrony in %(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- End-diastolic and end-systolic pressure in mmHg(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- End-diastolic and end-systolic volume in mL(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- Successful weaning from VA-ECMO(48 hours after study measurements)
- Tau in ms(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(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- Minimal and maximal dP/dt in mmHg/s(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
- Starling Contractile Index in mmHg/mL(Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min))
研究者
Nicolas van Mieghem
Head of Interventional Cardiology, Principal Investigator, Clinical Professor
Erasmus Medical Center