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NCT Number: NCT02531581

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nice

Nice, 06000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc

Other names: diuretic vascular filling

NaCl 9% isotonic

Drug

normal saline 500 cc / 4 hours and 1 L / 24 hours

Other names: fluid replacement

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Aug 24, 2015
Registry last updated: Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed