Arterial DiseasePOEMENCT03478709
Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level
An observational study of Arterial Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Disease
- What is being tested?
- volume expansion and norepinephrine
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2017to 19 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to intensive care
Who may be able to join
- Adult patients admitted to intensive care, for whom the physician has decided, in accordance with the care protocols of the service, to provide treatment for preload dependence or post-operative vasoplegia syndrome,
- patients monitored by a central venous catheter, a measurement of blood pressure with continuous monitoring of cardiac output by calibrated analysis of the pulse wave contour (PICCO or EV1000),
- Patients with sinus heart rate,
- Patients covered by a social insurance system,
- Patients who have given their oral consent to participation after complete information
Who cannot join
- Modification of therapies during the study period,
- Rhythm disorder with PM
- Appearance of cardiac rhythm disturbances (Ac / Fa, Tac / Fa, TV, FV).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level (POEME)
The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. the hypothesis is that Eadyn is an indirect reflect of capillary pressure (PCC).
Read the detailed description
The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. One hypothesis is that Eadyn is an indirect reflection of capillary pressure (PCC). The main objective of this project is to study the correlation between the measure of Eadyn and the PCC. The study begins when the physician in charge of the patient decides a hemodynamic treatment (either volume expansion or norepinephrine). The indication of the treatment is left to the discretion of the physician in charge of the patient: volume expansion or vasopressor agent. After verification of inclusion criteria, the physician collects demographic, ventilatory, hemodynamic, cardiac ultrasound data, and the type of treatment initiated (volume expansion, norepinephrine, and their dosages). 15 minutes after the introduction of the therapy and stabilization of the hemodynamic state, a new series of measurements of the aforementioned.
- Conditions
- Arterial Disease
- Being tested
- volume expansion, norepinephrine
- Keywords
- vasoplegia, dynamic arterial elastance, microcirculation
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume expansionOther
Volume expansion when the patient has a dependent preload evaluated by a positive leg lever test (variation of more than 10% of the VES). It corresponds to the intravenous administration of 500 ml of Ringer lactate over 10 min.
norepinephrineOther
Vasopressor agent when the patient has persistent arterial hypotension related to postoperative vasoplegia syndrome. Norepinephrine is administered during persistent hypotension (MAP <60mmHg) despite volume expansion. It corresponds to continuous intravenous norepinephrine administration to obtain a MAP of more than 70 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Volume expansion | Not described Receives: Other: volume expansion | |
| norepinephrine | Not described Receives: Other: norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess correlation between Eadyn and PCC measure
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start22 Oct 2017
- Primary completion22 Apr 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478709
- Sponsor's protocol ID
- PI 2017_843_0012
- Acronym
- POEME
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2018
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.
PubMed 34017263
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level (POEME)
- ClinicalTrials.gov ID
- NCT03478709
- Acronym / sponsor ID
- POEME / PI 2017_843_0012
- Conditions
- Arterial Disease
- Keywords
- vasoplegia, dynamic arterial elastance, microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 27 Mar 2018 (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.
The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. the hypothesis is that Eadyn is an indirect reflect of capillary pressure (PCC).
Detailed description
The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. One hypothesis is that Eadyn is an indirect reflection of capillary pressure (PCC). The main objective of this project is to study the correlation between the measure of Eadyn and the PCC. The study begins when the physician in charge of the patient decides a hemodynamic treatment (either volume expansion or norepinephrine). The indication of the treatment is left to the discretion of the physician in charge of the patient: volume expansion or vasopressor agent. After verification of inclusion criteria, the physician collects demographic, ventilatory, hemodynamic, cardiac ultrasound data, and the type of treatment initiated (volume expansion, norepinephrine, and their dosages). 15 minutes after the introduction of the therapy and stabilization of the hemodynamic state, a new series of measurements of the aforementioned.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume expansion | – | Other: volume expansion |
| norepinephrine | – | Other: norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to intensive care
Key inclusion criteria (5 listed)
- Adult patients admitted to intensive care, for whom the physician has decided, in accordance with the care protocols of the service, to provide treatment for preload dependence or post-operative vasoplegia syndrome,
Key exclusion criteria (3 listed)
- Modification of therapies during the study period,
- Rhythm disorder with PM
- Appearance of cardiac rhythm disturbances (Ac / Fa, Tac / Fa, TV, FV).
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 |
|---|---|---|
| volume expansionVolume expansion when the patient has a dependent preload evaluated by a positive leg lever test (variation of more than 10% of the VES). It corresponds to the intravenous administration of 500 ml of Ringer lactate over 10 min. | Other | Volume expansion |
| norepinephrineVasopressor agent when the patient has persistent arterial hypotension related to postoperative vasoplegia syndrome. Norepinephrine is administered during persistent hypotension (MAP <60mmHg) despite volume expansion. It corresponds to continuous intravenous norepinephrine administration to obtain a MAP of more than 70 mmHg | Other | norepinephrine |
Primary outcome
to assess correlation between Eadyn and PCC measure
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 34017263Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arterial Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess correlation between Eadyn and PCC measure (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478709, which also lists 1 linked publication.
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 18 Jul 2025.