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Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive

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ClinicalTrials.gov Identifier: NCT02531581
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains high. If anticoagulation is perfectly codified, the remainder of the initial management has been less studied.

In particular, the "conditioning" Initial often involves systematic plasma volume of 250 to 500 cc, by analogy to other situations. But this treatment option is not based on factual data. In the right ventricular dysfunction that often accompany severe EP, volume expansion may instead be harmful, according to the law of Frank Starling. A retrospective study has recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive EP.

The proposed study is interventional, prospective, multicenter, randomized, require to include 60 patients.

The main objective of the study is the comparison of the troponin normalization period Ic (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of a serious normotensive EP, between the 2 groups diuretic and filling Vascular.

The primary endpoint is the time in hours standardization of troponin Ic.

The secondary endpoints will be:

  • the period of normalization of Brain Natriuretic Peptide (BNP)
  • changes in echocardiographic parameters of right ventricular dysfunction
  • a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of thrombolysis.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Furosemide Drug: NaCl 9% isotonic Phase 4

Detailed Description:

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

PRINCIPAL 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

PRINCIPAL 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 XML File Identifier: cthC5Fc14NkHBXHkFCiTvGcJ8a8= Page 15/26 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive
Actual Study Start Date : December 23, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosémide

Furosemide: a dose of 40 mg IV bolus initially and live according to the diuretic response: possibility of 2nd Live IV bolus 40 mg if urine output <500 cc / 24 at the 4th hour.

Establishment of an infusion G5 500cc% in "vein custody."

Drug: Furosemide
furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc
Other Name: diuretic vascular filling

Active Comparator: NaCl 9% isotonic
Infusion of 500 cc of isotonic NaCl 9% in 4 hours and 1000 cc 24-hour peripheral vein. The filling is being used in an "empirical" in severe EP and this group is therefore the control group.
Drug: NaCl 9% isotonic
normal saline 500 cc / 4 hours and 1 L / 24 hours
Other Name: fluid replacement




Primary Outcome Measures :
  1. Time normalization hours Troponin Ic. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 XML File Identifier: cthC5Fc14NkHBXHkFCiTvGcJ8a8=
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531581


Contacts
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Contact: Emile FERRARI ferrari.e@chu-nice.fr
Contact: Elie SCHOUVER schouver.e@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Emile FERRARI       ferrari.e@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Emile FERRARI Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02531581     History of Changes
Other Study ID Numbers: 14-AOI-11
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Furosemide
Pulmonary Embolism
Embolism
Ventricular Dysfunction
Ventricular Dysfunction, Right
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action