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

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).

Study Overview

• Status: Unknown
• Conditions: Arterial Disease
• Intervention / Treatment: Other: volume expansion; Other: norepinephrine

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Pierre-Grégoire Guinot, Doctor; Phone Number: +333 22 08 78 99; Email: guinot.pierregregoire@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Pierre-Grégoire Guinot, Doctor; Phone Number: +33 3 22 08 78 99; Email: guinot.pierregregoire@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to intensive care

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Volume expansion	Other: volume 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.
norepinephrine	Other: norepinephrine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to assess correlation between Eadyn and PCC measure	15 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2017
• Primary Completion (Anticipated): April 22, 2018
• Study Completion (Anticipated): April 22, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: microcirculation; vasoplegia; dynamic arterial elastance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: PI 2017_843_0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No