Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure?

Completed

• Conditions: Preload-responsiveness

• Registration Number: NCT05538637
• Lead Sponsor: Avicenna Military Hospital

Brief Summary

The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.

Detailed Description

Adult patients with acute circulatory failure will be included in the study. An initial echocardiography is performed in patients placed in a semi-recumbent position. On the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (LVOT-VTI) and mitral valve (MV-VTI) velocity time integral are measured (baseline values). Then a passive leg raise test is performed and the parameters (LVOT-VTI and MV-VTI) are measured again. Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10%. In preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. Immediately after fluid therapy, the same parameters are recorded during a third echocardiography. An increase of 10% or more of LVOT-VTI , compared with baseline, defines fluid responsiveness. Patients are monitored using the standard of care practices. Hemodynamic assessment includes repetitive echocardiographic examinations if needed. In patients with shock, invasive blood pressure is monitored with an arterial catheter.

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Study Start: 2022-11-06
• Status Verified: 2024-11
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Acute circulatory failure.

Exclusion Criteria

• Recent surgery (<5 days)
• Suspected or confirmed intra-abdominal hypertension.
• Intracranial hypertension.
• Severe mitral valve disease: Severe mitral insufficiency or severe mitral stenosis
• Acute cor pulmonale
• Atrial fibrillation
• Low echogenicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness	through study completion, an average of 6 months	Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after passive leg raising) to discriminate preload-responsive patients.
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness	through study completion, an average of 6 months	Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after fluid loading with 500 ml of saline) to discriminate fluid-responsive patients.

Trial Locations

Locations (1)

Avicenna Military Hospital; 🇲🇦 Marrakesh, Marrakesh Tensift El Haouz, Morocco