Clinical trial NCT05888974: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients with shock (MAP \< 65 mmHg) requiring vascular filling indicated by the referring physician physician, recruited consecutively in the emergency department of the CHU of Nîmes and Montpellier.

Brief summary: 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.

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

Primary outcomes:
measure: E' variation (∆E')
timeFrame: Inclusion time
measure: Fluid filling responsiveness
timeFrame: Inclusion time
Secondary outcomes:
measure: ∆E'late
timeFrame: Inclusion time
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
References: