An observational study in Preload-responsiveness, sponsored by Avicenna Military Hospital. Completed at 1 site in Morocco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Avicenna Military Hospital · Observational
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.
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.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 247 observational studies indexed under Shock.
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Adult patients with acute circulatory failure, with or without arterial hypotension. Acute circulatory failure is defined by the presence of signs of tissue hypoperfusion : prolonged capillary refil time (>5 seconds), mottling, acrocyanosis, oliguria (\<0.5 mL/kg/h for more than an hour), altered mental status, lactate>2 mmol/l or metabolic acidosis (pH\<7.35, base excess >-5). Arterial hypotension is defined by systolic blood pressure (SBP) \< 90mmHg, mean arterial pressure (MAP) \< 65 mmHg or a drop in SBP ≥ 40 mmHg. Shock is defined by the association of an acute circulatory failure and arterial hypotension.
Inclusion Criteria: Acute circulatory failure.
Exclusion Criteria:
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.
Also known as: Mitral velocity time-integral variability
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness
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.
Time frame: through study completion, an average of 6 months
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness
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.
Time frame: through study completion, an average of 6 months
Plan to share: Yes — The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After study completion for 2 years
Access criteria: healthcare workers
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Avicenna Military Hospital