Diagnostic Performance of the Mitral Annulus Velocity Variation Measured by Tissue Doppler to Evaluate the Fluid Responsiveness During the Initial Management of Shock in Patients Admitted to the Emergency Department

Overview

Assessing the response to vascular filling in shock is a challenge in emergency medicine. The mitral annulus velocity measured by tissue Doppler (E') has recently been characterized as sensitive to the preload conditions of a patient. The investigators hypothesize that the E' variation (∆E') before and after fluid filling allows us to assess the response to vascular filling. The investigators hypothesize that the ∆E' has a good diagnostic performance to establish whether a patient is responsive to fluid filling, defined by an area under the ROC curve greater than 0.75.

Detailed description

Assessing the response to vascular filling in shock is a challenge in emergency medicine.

Trans thoracic ultrasound (TTS) is recommended for the diagnosis and management of this type of patient. TTS allows real-time monitoring of the effectiveness of a therapeutic . In case of circulatory failure without cardiac failure, it is recommended to perform fluid filling tests based on an increase in of indicators to assess preload dependence. The change in subaortic VTI, which has become the gold standard in clinical practice for diagnosing fluid filling response, suffers from a lack of technical feasibility. The mitral annulus velocity measured by tissue Doppler (E') has recently been characterized as sensitive to the preload conditions of a patient. The high feasibility of this technique makes its study interesting for the evaluation of the preload (and its variation after variation after vascular filling) of the patient in shock in the emergency department. To our knowledge, there are no clinical studies exploring the relevance of this technique to evaluate fluid filling response in patient admitted with shock in the emergency department.

The investigators hypothesize that the E' variation (∆E') before and after fluid filling allows us to assess the response to vascular filling. The investigators hypothesize that the ∆E' has a good diagnostic performance to establish whether a patient is responsive to fluid filling, defined by an area under the ROC curve greater than 0.75.

The main objective of this study is to investigate the diagnostic performance of ∆E' in establishing response to fluid filling in a prospective cohort of patients admitted to the emergency department with shock requiring vascular filling.

Interventions

• Diagnostic test Cardiac ultrasonography
  During the inclusion visit, the patient will receive 3 cardiac ultrasonography. The first one will be performed at the time of the initiation of the 500mL vascular filling (T0), without delaying and the second one after the end of the filling (Tfin). These first two ultrasound are part of standard practice. A third will be performed 20 minutes after the end of the vascular filling (Tfin+20).

Primary outcome measures

• E' variation (∆E') [Time frame: Inclusion time]
• Fluid filling responsiveness [Time frame: Inclusion time]

Secondary outcome measures (1)

• ∆E'late [Time frame: Inclusion time]

Eligibility criteria

Inclusion criteria

• Patient has been informed of the study and does not refuse to participate.
• Patient is at least ≥ 18 years of age.
• The patient must be beneficiary of a health insurance plan.
• Patient has shock with a mean blood pressure less than 65 mmHg (<)
• The patient does not have acute intracranial pathology
• The referring physician has decided on a vascular filling with 500mL of crystalloids (NaCl 0.9% or Ringer lactate)

Exclusion criteria

• The patient has already received 2 vascular fillings since the beginning of his management
• The patient is in shock and has a contraindication to vascular filling : shock of a cardiogenic or obstructive nature
• The patient has an intracranial pathology requiring maintain a MAP ≥ 80 mmHg
• The patient is intubated or on Non-Invasive Ventilation before the vascular filling
• The patient is under court protection
• The patient is pregnant, parturient or nursing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• CHU de Nîmes — Nîmes

Identifiers

NCT: NCT05888974 · 2023-A00022-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗