Primary objective of this study is to enhance insight in differences in elemental cardiovascular physiology between different levels of VA-ECMO support, by comparing pressure-volume loop derived parameters between 4.0-3.0-2.0-1.0-0.5 L/min…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
multi-orgaanfalen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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 left ventricular afterload as well as right ventricular
distention during VA-ECMO and 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, are limited. We hypothesize
biventricular pressure-volume loop measurement will enhance understanding of
elemental cardiovascular physiology during different levels of VA-ECMO support.
Besides, pressure-volume loop measurement will hypothetically provide
opportunities in discovering novel predictors for successful weaning from
VA-ECMO support.
A substudy will be added to the protocol investigating the interaction between
PEEP and LV end-diastolic volume.
Study objective
Primary objective of this study is to enhance insight in differences in
elemental cardiovascular physiology between different levels of VA-ECMO
support, by comparing pressure-volume loop derived parameters between
4.0-3.0-2.0-1.0-0.5 L/min extracorporeal VA-ECMO blood flow. The secondary
objective is to distinguish patients who will be successfully weaned from
VA-ECMO versus patients who will fail to be weaned from VA-ECMO, based on
pressure-volume loop derived parameters during the VA-ECMO *weaning trial* (on
0.5L/min extracorporeal blood flow).
Study design
Single-centre clinical observational study with invasive measurements.
Study burden and risks
The study is group-related: study questions could not be answered without
participation of subjects belonging to the group in question. The expected
burden for the enrolled subject is considered moderate, e.g. given the
necessity for transporting an ICU patient on VA-ECMO support from ICU to the
department of Interventional Cardiology. The potential risks are also
considered moderate and comparable to diagnostic heart catheterization without
the necessity of additional vascular puncture. Enrolled patients do not benefit
from study participation, neither will individual study results (or pressure
volume loop data obtained during study enrolment) influence the individual
(ICU-) treatment strategy.
Potential complications of the alveolar recruitment (e.g. barotrauma and
hemodynamic instability) are considered negligible as the safe airway pressure
threshold (defined as Peak Pressure < 40 cmH20) will be safeguarded
continuously during the study measurement.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
- Age < 18 years.
- Re-initiation of VA-ECMO during the same ICU admission.
In conclusion, all patients with established VA-ECMO support are eligible for
study participation: clinical grounds and conditions are irrelevant for study
inclusion, given the study*s objective of identifying changes in baseline
physiology induced by VA-ECMO support.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78360.078.21 |