Right ventricular necrosis increases patient in hospital mortality and can be observed in 20-50% of patients admitted for during acute myocardial infarction. Current guidelines recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV load using fluid expansion and if insufficient adding inotropic support. However, several experimental studies reported a potential deleterious effect of right ventricular dilation related to fluid expansion because right and left ventricular interaction decreases stroke volume and cardiac output. Consistently with these finding, a study on a small patient sample conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in patients with right ventricular necrosis. The present study is a phase 3, interventional, prospective, randomized, multicenter, double-blind analysis by intention to treat. The main objective is to demonstrate improved hemodynamic parameters in the short term in patients admitted for acute myocardial infarction with extension RV treated with furosemide. The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide. The study population will consist in 88 patients and the duration of subjects' participation will be one month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Furosemide: Special LASILIX (250 mg/25 ml) solution for injection reconditioned glass bottle like "penicillin" of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial)
Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
Placebo furosemide: glucose 5% for injection reconditioned glass bottle like "penicillin" of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial).
Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
Henri Mondor Hospital
Créteil, France
Improvement in cardiac output (measured by Doppler method) defined by an increase of more than 10% 24 hours after administration of the treatment in patients admitted and treated by either fluid expansion or furosemide.
Time frame: At Hour 24
Intra-hospital mortality
Time frame: an average of 10 days after inclusion
Rate of inotropic support
Time frame: an average of 10 days after inclusion
Number of hemodynamic instability requiring fluid expansion
Time frame: an average of 10 days after inclusion
Change in systolic blood
Time frame: Hour 24
Change in heart rate
Time frame: Hour 24
Urine output
Time frame: Hour 24
The duration of hospitalization in intensive care
Time frame: an average of month 1
Hospitalizations for cardiovascular reason one month after acute myocardial infarction
Time frame: month 1
One month mortality
Time frame: month 1
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