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

NCT05888974 | Recruiting

• 1 other identifier: 2023-A00022-43
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Outcome Measures

Primary Outcomes (2)

• 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.

  Inclusion time

• 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%.

  Inclusion time

Secondary Outcomes (1)

• ∆E'late

  Inclusion time

Study Arms (1)

patients with shock (MAP < 65 mmHg) requiring vascular filling

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.

Diagnostic Test: Cardiac ultrasonography

Interventions

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).

patients with shock (MAP < 65 mmHg) requiring vascular filling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 34000, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura GRAU MERCIER, MD

CONTACT

+33675169725; laura.merciergr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

FR (1)