Comparing a diuretic vascular filling in the initial management of acute pulmonary embolism with right ventricular dysfunction normotensive

Phase 1

• Conditions: acute pulmonary embolism with right ventricular dysfunction normotensive; MedDRA version: 18.0Level: LLTClassification code 10050071Term: Embolism lungSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003273-42-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-29
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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 <16 mm and S 'pulsed TDI tricuspid <10 cm / sec) or pulmonary arterial hypertension (PAH) Pulmonary Arterial Pressure with systolic (PAPs)> 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

• Thrombolysis before inclusion
• State of cardiogenic shock defined as systolic BP <90 mmHg or a drop of> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified