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

September 24, 2020 updated by: Centre Hospitalier Universitaire de Nice

Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed for the duration of hospital stay, an expected average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Emile FERRARI, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2015

Primary Completion (Actual)

April 9, 2020

Study Completion (Actual)

April 9, 2020

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-AOI-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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