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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT02531581

Collaborator

(none)

Enrollment

Location

Arms

51.5

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual 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 :

Dec 23, 2015

Actual Primary Completion Date :

Apr 9, 2020

Actual Study Completion Date :

Apr 9, 2020

Arms and Interventions

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 Names: 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 Names: fluid replacement

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 Names:

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 Names:

fluid replacement

Outcome Measures

Primary Outcome Measures

Time normalization hours Troponin Ic. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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