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
| NCT ID | NCT05888974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 187 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-08-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 187 participants in total. It began in 2023-08-01 with a primary completion date of 2026-08-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05888974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05888974 currently recruiting?
Yes, NCT05888974 is actively recruiting participants. Contact the research team at laura.merciergr@gmail.com for enrollment information.
Where is the NCT05888974 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT05888974 clinical trial?
NCT05888974 is sponsored by Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 187 participants.