Pulmonary Embolism With Right Ventricle Enlargement Clinical Trial
Official title:
Diuretic Versus Placebo in Pulmonary Embolism With Right Ventricular Enlargement: a Double-blind Randomized Controlled Study
Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about
75000 cases in France and a short-term mortality rate of about 10%. Death is usually related
to an acute right ventricular (RV) failure due to the increase in right ventricular
afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in
case of shock. However several studies suggest that fluid expansion may worsen acute RV
failure by increasing RV dilatation and ischemia and left ventricular compression by RV
dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of
fluid expansion. In a preliminary study published by our group, we showed that diuretic
treatment in the setting of PE with RV dilatation is safe and is associated with an increase
in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients
with oliguria. This may be related to the decrease of ventricular interdependence and
enhancement of both LV and RV function.
The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in
patients referred for acute PE with RV dilatation compared to placebo. The combination of
urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it
indicates the disappearance of pre-shock symptoms and is therefore associated with a lower
event risk. Thus, it allows early discharge of the patients from the intensive care unit.
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