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CompletedNCT03478709POEMEUpdated Jul 18, 2025

Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level

An observational study in Arterial Disease, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Arterial Disease

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Keywords

  • vasoplegia
  • dynamic arterial elastance
  • microcirculation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to intensive care

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Modification of therapies during the study period,
  • Rhythm disorder with PM
  • Appearance of cardiac rhythm disturbances (Ac / Fa, Tac / Fa, TV, FV).
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Volume expansion

    Other: volume expansion

  • norepinephrine

    Other: norepinephrine

Interventions

  • Othervolume expansion

    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.

  • Othernorepinephrine

    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

05

What researchers measure

Primary outcomes

  1. to assess correlation between Eadyn and PCC measure

    Time frame: 15 minutes

06

Study locations

1 site
  • CHU Amiens-Picardie
    Amiens, 80054, France
07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03478709
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Oct 22, 2017
Primary completion
Apr 22, 2020
Completion
Dec 19, 2020
Last update
Jul 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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