Clinical Trial: Diuretic Versus Placebo in Pulmonary Embolism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Diuretic Versus Placebo in Pulmonary Embolism With Right Ventricular Enlargement: a Double-blind Randomized Controlled Study

Brief Summary:

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.

Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Primary end point will be a combined clinical criterion, to reach the primary endpoint, patients have to meet all the following criteria: - Urine output> 0.5ml/kg/h - Normalization of clinical parameters of simplified PESI score [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• patients have to meet all the four following criteria: - Urine output> 0.5ml/kg/h over 24 hours - Normalization of clinical parameters of simplified PESI score - Urine output [ Time Frame: 48 hours ]

  Normalization of clinical parameters of simplified PESI score :

  • Heart Rate<110/min
  • Systolic blood pressure≥100mmHg
  • Arterial oxyhemoglobin level>90% on room air or after 5 minutes of oxygen withdrawal.
• - Composite criteria including death, need for catecholamine, cardiac arrest and mechanical ventilation during hospitalization and at 1 month from inclusion - NYHA score [ Time Frame: In hospital and 1 month ]
• o RV/LV ratio and decrease from baseline o Systolic pulmonary pressure and decrease from baseline o Tricuspid annular plane systolic expansion (TAPSE) at o Tricuspid annular plane systolic expansion (TAPSE) variation from baseline [ Time Frame: 24 hours abd 1 month ]
  RV/LV ratio (diameters and surfaces)
• - NT-proBNP or BNP decrease at 24hours - Creatinin and liver enzymes variations at 24hours [ Time Frame: 24 hours ]

Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 16, 2014
Date Started: November 2014
Date Completion: December 2017
Last Updated: October 5, 2015
Last Verified: October 2015