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
About this trial
This is an interventional treatment trial for Pulmonary Embolism
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
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
NCT ID
NCT02531581
First Posted
February 20, 2015
Last Updated
September 24, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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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