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Clinical Trials/EUCTR2014-003273-42-FR
EUCTR2014-003273-42-FR
Active, not recruiting
Phase 1

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

CHU de Nice0 sites0 target enrollmentJune 29, 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHU de Nice
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 29, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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
  • \- 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

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

Outcomes

Primary Outcomes

Not specified

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