NCT03478709

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

February 28, 2018

Last Update Submit

July 17, 2025

Conditions

Keywords

vasoplegiadynamic arterial elastancemicrocirculation

Outcome Measures

Primary Outcomes (1)

  • to assess correlation between Eadyn and PCC measure

    15 minutes

Study Arms (2)

Volume expansion

Other: volume expansion

norepinephrine

Other: norepinephrine

Interventions

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.

Volume expansion

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

norepinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to intensive care

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vasoplegia

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 27, 2018

Study Start

October 22, 2017

Primary Completion

April 22, 2020

Study Completion

December 19, 2020

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations