Diuretic Versus Placebo in Pulmonary Embolism
Diuretic Versus Placebo in Pulmonary Embolism
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.
Inclusion Criteria:

 Patients aged 18 years and over with

 1. Symptomatic acute pulmonary embolism with first clinical symptoms within 15 days, and
 objectively confirmed by CT scan

 2. RV dysfunction (≥1 criterion) confirmed by elevated BNP value or echocardiography or
 spiral computed tomography of the chest:

 -  Echocardiography

 o Right/Left ventricular end diastolic diameter > 1(apical or subcostal 4-chamber
 view)

 -  Computed tomography

 o Right/Left short-axis diameter ratio>0.9 (transverse plane)

 -  Positive Nt-proBNP (>600) or BNP>200 pg/mL

 3. One abnormal following PESI criteria

 -  Heart Rate>110/min

 -  Systolic blood pressure<100mmHg

 -  Arterial oxyhemoglobin level<90% on room air or after 5 minutes of oxygen
 withdrawal.

 Exclusion Criteria:

 -  Cardiogenic shock requiring thrombolysis

 -  Previous significant left ventricular insufficiency (LVEF<45%)

 -  Systolic blood pressure<90mmHg at admission

 -  Age ≤ 18 years

 -  Pregnancy

 -  No health insurance

 -  Patients deprived of liberty or under legal protection

 -  Creatinin clearance <30mL/min/m²

 -  hypersensibility to furosemide or its excipients

 -  functional renal insufficiency

 -  Hepatic encephalopathy

 -  Urinary tracks obstruction

 -  Hypovolemia or dehydration.

 -  Sever hypokalemia (K+ < 3mmol/L)

 -  Severe hyponatremia (Na+ < 125mmol/L)

 -  Ongoing hepatitis and hepatic insufficiency severe in patients with renal
 insufficiency or dialysis