Evaluating fluid responsiveness in shock patients using tissue Doppler

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

This study is testing if measuring heart movement with ultrasound can help doctors tell if patients in shock will benefit from receiving extra fluids.

Quick facts

• Study type: Observational
• Enrollment: 187 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT05888974 on ClinicalTrials.gov

What this trial studies

This study assesses the diagnostic performance of mitral annulus velocity variation measured by tissue Doppler to evaluate fluid responsiveness in patients experiencing shock. It involves using trans thoracic ultrasound to monitor changes in the mitral annulus velocity before and after administering a fluid challenge. The goal is to determine if the variation in velocity can reliably indicate whether a patient will respond positively to fluid resuscitation. The study aims to establish a diagnostic performance threshold defined by an area under the ROC curve greater than 0.75.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are experiencing shock with a mean blood pressure less than 65 mmHg.

Not a fit: Patients with cardiogenic or obstructive shock, or those who have contraindications to fluid filling, will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the management of shock patients by providing a reliable method to assess fluid responsiveness.

How similar studies have performed: While this approach is novel in the context of shock management, similar studies using tissue Doppler for fluid responsiveness have shown promising results.

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

Where this trial is running

Nîmes

• CHU de Nîmes — Nîmes, France (Recruiting)

Study contacts

• Study coordinator: Laura GRAU MERCIER, MD

Conditions Shock