Status:
UNKNOWN
Diuretic Versus Placebo in Pulmonary Embolism
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pulmonary Embolism With Right Ventricle Enlargement
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 righ...
Eligibility Criteria
Inclusion
- Patients aged 18 years and over with
- Symptomatic acute pulmonary embolism with first clinical symptoms within 15 days, and objectively confirmed by CT scan
- 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
- 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
- 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
Key Trial Info
Start Date :
April 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT02268903
Start Date
April 13 2015
End Date
May 1 2018
Last Update
October 19 2017
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94010