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OpenTrials
Completed

NCT Number: NCT05538637

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicenna Military Hospital

Marrakesh, Marrakesh Tensift El Haouz, 40000, Morocco

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Diagnostic Test

Mitral velocity time-integral variability measurement before and after passive leg raising.

Mitral velocity time-integral variability measurement after fluid loading in preload-responsiveness patients.

Other names: Mitral velocity time-integral variability

Primary outcomes

  1. Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness

    Time frame: 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.

  2. Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Avicenna Military Hospital

Other

Registry information

Official study title

Reliability and Accuracy of Mitral Velocity Time-integral Variability With Passive Leg Raising as a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure in the ICU.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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