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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.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51884
Enrollment
20
Registered
2021-07-13
Start date
2023-02-28
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combined refractory respiratory and hemodynamic failure organ failure Combined refractory respiratory and hemodynamic failure organ failure

Interventions

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: On VA-ECMO support for any indication. According to our centre*s protocol, indications for VA-ECMO initiation are hemodynamic and/or respiratory failure, cardiogenic shock, (accidental) hypothermia, ECPR, bridge to cardiac assist device implant and bridge to heart (and/or lung) transplant. In short, all patients on VA-ECMO support are eligible for study participation, irrespective of their clinical indication for VA-ECMO initiation. We foresee study results will not be influenced by patient selection, since study inclusion criteria do not comprise any clinical conditions.

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

MeasureTime frame
Primary study endpoints are the biventricular pressure volume loop characteristics reflecting cardiac mechanoenergetics, including stroke work and potential energy (together extrapolated into the pressure volume area) compared between 4.0-3.0-2.0-1.0-0.5 L/min VA-ECMO blood flow in individual patients. Regarding the substudy: The difference in LV preload in individual VA-ECMO patients, reflected by the LV PVL derived parameter End-Diastolic Volume (EDV in mL). this parameter will be measured at 100% VA-ECMO blood flow for each PEEP level (i.e. 20, 10 and 0 cmH20).

Secondary

MeasureTime frame
Secondary endpoints are differences in additional biventricular pressure-volume loop parameters between 4.0-3.0-2.0-1.0-0.5 L/min extracorporeal VA-ECMO blood flow, including stroke volume, (forward and power) cardiac output, preload recruitable stroke work, tau, intraventricular dyssynchrony (both systolic and diastolic), dP/dt (maximal and minimal), effective arterial elastance and end-systolic elastance (the ratio between both reflecting ventricular-arterial coupling), the ventricular stiffness constant β, end-diastolic volume, end-diastolic pressure (including the end-diastolic pressure volume relation, EDPVR, trendline) as well as end-systolic volume, end-systolic pressure (including the end-systolic pressure volume relation, ESPVR, trendline), Starling Contractile index, stroke work to pressure volume area ratio as well as the ventricular volume on 0, 15, 30 and 100 mmHg ventricular pressure.

Countries

Netherlands

Contacts

Public ContactC.L. Meuwese

Erasmus MC, Universitair Medisch Centrum Rotterdam

c.meuwese@erasmusmc.nl+31 (06) 31135752

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026