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

ConditionShock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 (<)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac ultrasonography

    Diagnostic test

    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).

Treatment groups

187 Participants
are divided into 1 treatment group
Group A: patients with shock (MAP < 65 mmHg) requiring vascular filling1 intervention

Trial outcomes

Primary outcomes

1

E' variation (∆E')

The E' wave will be measured by tissue Doppler at the initiation (T0) of the filling and after the end of the vascular (Tfin) to determine its variation (%) between these two times of measurement.

Time frame
Inclusion time
2

Fluid filling responsiveness

Vascular filling is defined by the intravenous administration of 500 mL of crystalloid for 20 to 30 minutes, decided by the physician in charge. The response to filling will be evaluated by the variation of the time velocity index between T0 and Tfin (∆ITV) measured with pulsed Doppler. Patients will be considered : * Responder (R) group if ∆ITV ≥ 15% * Nonresponder group (NR) if ∆ITV \< 15%.

Time frame
Inclusion time

Secondary outcomes

1

∆E'late

∆E'late: the E' wave will be measured by trans thoracic ultrasound before vascular filling (T0) and 20 minutes after the end of vascular filling (Tfin+20) to determine its variation (%) between these two times of measurement.

Time frame
Inclusion time

Other outcomes

Sponsors and contacts

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