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

NCT02531581 | Completed Phase 4

• 1 other identifier: 14-AOI-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Time normalization hours Troponin Ic.

  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.

  participants will be followed for the duration of hospital stay, an expected average of 12 hours

Study Arms (2)

Furosémide

EXPERIMENTAL

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

NaCl 9% isotonic

ACTIVE COMPARATOR

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

Interventions

Furosemide DRUG

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

Also known as: diuretic vascular filling

Furosémide

NaCl 9% isotonic DRUG

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

Also known as: fluid replacement

NaCl 9% isotonic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

• Ferrari E, Sartre B, Labbaoui M, Heme N, Asarisi F, Redjimi N, Fourrier E, Squara F, Bun S, Berkane N, Breittmayer JP, Doyen D, Moceri P. Diuretics Versus Volume Expansion in the Initial Management of Acute Intermediate High-Risk Pulmonary Embolism. Lung. 2022 Apr;200(2):179-185. doi: 10.1007/s00408-022-00530-5. Epub 2022 Apr 5.

  PMID: 35381867 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Furosemide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Emile FERRARI

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: August 24, 2015
• Study Start: December 23, 2015
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: September 25, 2020

Record last verified: 2018-02

Locations

FR (1)