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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Furosemide
NaCl 9% isotonic
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Furosémide

NaCl 9% isotonic

Arm Description

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."

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2015
Last Updated
September 24, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02531581
Brief Title
Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive
Official Title
Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 23, 2015 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
April 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Furosémide
Arm Type
Experimental
Arm Description
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."
Arm Title
NaCl 9% isotonic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
diuretic vascular filling
Intervention Description
furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc
Intervention Type
Drug
Intervention Name(s)
NaCl 9% isotonic
Other Intervention Name(s)
fluid replacement
Intervention Description
normal saline 500 cc / 4 hours and 1 L / 24 hours
Primary Outcome Measure Information:
Title
Time normalization hours Troponin Ic.
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emile FERRARI
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35381867
Citation
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.
Results Reference
derived

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

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