Clinical Trials Directory

Trials / Completed

CompletedNCT03478709

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

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

Interventions

TypeNameDescription
OTHERvolume 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.
OTHERnorepinephrineVasopressor 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

Timeline

Start date
2017-10-22
Primary completion
2020-04-22
Completion
2020-12-19
First posted
2018-03-27
Last updated
2025-07-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03478709. Inclusion in this directory is not an endorsement.