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) (PLUTO-I)

January 3, 2024 updated by: Nicolas van Mieghem, Erasmus Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus Medical Center
        • Contact:
        • Principal Investigator:
          • Nicolas M Van Mieghem, Prof MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adult patients on VA-ECMO support for any indication

Description

Inclusion Criteria:

- On VA-ECMO support for any indication

Exclusion Criteria:

  • Age < 18 years
  • Re-initiation of VA-ECMO during the same ICU admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational arm
Patients on VA-ECMO, eligible for weaning
Other: Pressure-volume loop measurements
Pressure-volume loop measurements using a conductance catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
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.
Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
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.
Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stroke Volume in mL
Time Frame: Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
By thermodilution, using pulmonary artery catheterization
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements (following application of concerning single-beat algorithms)
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
Expressed by PV-loop reconstructions based on conductance catheter measurements.
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)
I.e. ventricular volume at 0, 15, 30 and 100 mmHg, expressed by PV-loop reconstructions based on conductance catheter measurements.
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
Mortality, irrespective of etiology
Within 30 days after study measurements
Successful weaning from VA-ECMO
Time Frame: 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
48 hours after study measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLUTO-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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