acute pulmonary embolism with right ventricular dysfunction normotensive MedDRA version: 18.0 Level: LLT Classification code 10050071 Term: Embolism lung System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Furosémide
Product Name: Furosemid
Product Code: 3400956401062
Pharmaceutical Form: Injection
Trade Name: NaCl 9% isotonic
Product Name: NaCl 9% isotonic
Pharmaceutical Form: Injection
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • older than 18 Patient • Hospitalized in the first 24 hours of a serious EP normotensive formally diagnosed (by a chest CT) The serious nature without hypotension is defined by the presence of: - From biological criteria: troponin and / or BNP positive AND - In sonographic criteria: dilated right ventricle defined by echocardiography right over left ventricle ratio (VG)> 0.9 in apical 4-chamber or 0.7 in large parasternal axis and right ventricular systolic dysfunction (TAPSE 35 mmHg or paradoxical septum • Informed consent signed • Affiliation to social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Thrombolysis before inclusion • State of cardiogenic shock defined as systolic BP 40 mmHg in systolic BP for> 15 minutes • severe chronic renal impairment defined by clearance <30 ml / min. • pregnant or nursing woman (a pregnancy test will be performed for women of childbearing age and the results will be communicated to the patient by a doctor of his choice) • Most People under guardianship • hospitalized without their consent and not protected by law No • Private person of liberty • Residence time of more than 24 hours in another department after the positive diagnosis of pulmonary embolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compared with the time of normalization of cTnI (biomarker of right ventricular dysfunction) in hospitalized patients in the initial phase of a serious EP normotensive between the 2 groups diuretic and vascular filling;Secondary Objective: • Compare the time of normalization of BNP between the 2 groups. • Compare the evolution of ultrasound parameters between the 2 groups right ventricular dysfunction. • Compare changes in clinical factors: Blood pressure (BP), heart rate, oxygen requirements and diuresis • Compare the occurrence of complications of severe pulmonary embolism: o State of cardiogenic shock o Need for thrombolysis o Need to use amines • Compare the occurrence of death from any cause and death related to PE between the 2 groups • Compare the occurrence of ischemic stroke or hemorrhagic • Compare the length of stay in intensive care To assess the safety of diuretic treatment;Primary end point(s): Time normalization hours Troponin Ic. This is a direct assay on peripheral venous sampling, easy to collect, accurate and reproducible, made ??routines in biochemistry laboratories CHU Nice and Antibes CH. Assay kits are the same at the University Hospital of Nice and Antibes CH (BECKMANTM kit). The threshold of positivity of troponin is 0.07 ng / mL.;Timepoint(s) of evaluation of this end point: inclusion to 108 hours (12h) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Direct Determination of BNP, accurate, reproducible routinely performed in the laboratories of the University Hospital of Nice and Antibes CH whose positivity threshold of 100 pg / mL (Triage Kit BNPTM) • The right ventricular systolic function was assessed by ultrasound two commonly used parameters easily collected by transthoracic echocardiography: the TAPSE (Tricuspid Annular Plane Systolic Excursion) and peak velocity of the S wave to the side ring tricupide pulsed Doppler tissue . The threshold of normality is TAPSE> 16 mm [28]. The threshold of normality of the wave S tricuspid> 10 cm / second [28, 29] • ultrasound Other collected parameters: heart rate by measuring the right under ITV pulmonary pulsed Doppler pulmonary artery pressures with the flow of tricuspid insufficiency continuous doppler, dimensions in mm of the right ventricular apical four cavities and longitudinal deformation of right ventricle in speckle-tracking imaging (%). • Clinical factors identified in routine every 4 hours in intensive care units and intensive care: TA measured by automatic blood pressure, heart rate measured by scope, oxygen requirements identified on the sign constants and diuresis found on the sign constants. • Evaluation of the safety of diuretic treatment: serum potassium in mmol / l in the laboratory of Biochemistry and creatinine in mmol / l with estimating creatinine clearance by MDRD method ml / min biochemistry laboratory . • Complications of severe pulmonary embolism: o State cardiogenic shock defined by SBP 40 mmHg lasting more than 15 minutes in the absence of other causes of shock (hypovolemic, septic or hemorrhagic) o Need for thrombolysis if occurrence of cardiogenic shock o Need for treatment with dobutamine if occurrence of cardiogenic shock with oliguria or TA maintained (defined as urine output <1 cc / kg / hour) • Other complications: death, ischemic stroke or hemorrha | — |
Countries
France
Contacts
Public ContactClinical Research Associate
CHU de Nice
Outcome results
None listed