Extracorporeal Membrane OxygenationPLUTO-INCT05909280
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)
An observational study of Extracorporeal Membrane Oxygenation and Cardio/Pulm: Heart Failure, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Cardio/Pulm: Heart Failure
- What is being tested?
- Pressure-volume loop measurements
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2022to 14 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients on VA-ECMO support for any indication
Who may be able to join
- On VA-ECMO support for any indication
Who cannot join
- Age < 18 years
- Re-initiation of VA-ECMO during the same ICU admission
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Antoon JM van den Enden, MD, +31 70 308896, a.vandenenden@erasmusmc.nl
Nicolas M Van Mieghem, Prof MD PhD
About this study
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.
Read the 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.
- Being tested
- Pressure-volume loop measurements
- Keywords
- Pressure-volume loop, Cardiac mechanoenergetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-volume loop measurementsOther
Pressure-volume loop measurements using a conductance catheter
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | Patients on VA-ECMO, eligible for weaning Receives: Other: Pressure-volume loop measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Secondary outcomes (13)
Stroke Volume in mL
Expressed by PV-loop reconstructions based on conductance catheter measurements.
Measured: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Cardiac Output
By thermodilution, using pulmonary artery catheterization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
All-cause mortality
Mortality, irrespective of etiology
Measured: 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
Measured: 48 hours after study measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start14 Nov 2022
- Primary completion14 Nov 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas M Van Mieghem, Prof MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909280
- Sponsor's protocol ID
- PLUTO-I
- Acronym
- PLUTO-I
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05909280
- Acronym / sponsor ID
- PLUTO-I / PLUTO-I
- Keywords
- Pressure-volume loop, Cardiac mechanoenergetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm | – | Other: Pressure-volume loop measurementsPatients on VA-ECMO, eligible for weaning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients on VA-ECMO support for any indication
Key inclusion criteria (1 listed)
- On VA-ECMO support for any indication
Key exclusion criteria (2 listed)
- Age < 18 years
- Re-initiation of VA-ECMO during the same ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure-volume loop measurementsPressure-volume loop measurements using a conductance catheter | Other | Observational arm |
Primary outcome
Stroke Work in mmHg/mL
Time frame: 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
Time frame: 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
Time frame: 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.
13 secondary outcomes
Stroke Volume in mL
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Cardiac Output
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Preload recruitable stroke work in mmHg/mL
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Tau in ms
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Systolic and diastolic intraventricular dyssynchrony in %
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Minimal and maximal dP/dt in mmHg/s
Time frame: 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
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
End-diastolic and end-systolic pressure in mmHg
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
End-diastolic and end-systolic volume in mL
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Starling Contractile Index in mmHg/mL
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
V0, V15, V30 and V100 in mL
Time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
All-cause mortality
Time frame: Within 30 days after study measurements
Successful weaning from VA-ECMO
Time frame: 48 hours after study measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas M Van Mieghem, Prof MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Cardio/Pulm: Heart Failure, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoon JM van den Enden, MD (+31 10 7038896, a.vandenenden@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Work in mmHg/mL (time frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.