Pulmonary EmbolismPhase 4NCT02531581
Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive
A Phase 4 study testing Furosemide and NaCl 9% isotonic in people with Pulmonary Embolism, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Furosemide and NaCl 9% isotonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2015to 9 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- hospitalized without their consent and not protected by law No
- Private person of liberty
- Residence time of more than 24 hours in another
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Pulmonary Embolism
- Being tested
- Furosemide, NaCl 9% isotonic
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called diuretic vascular filling
furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc
NaCl 9% isotonicDrug
Also called fluid replacement
normal saline 500 cc / 4 hours and 1 L / 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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. Receives: Drug: NaCl 9% isotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start23 Dec 2015
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emile FERRARI, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531581
- Sponsor's protocol ID
- 14-AOI-11
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2015
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35381867
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive
- ClinicalTrials.gov ID
- NCT02531581
- Acronym / sponsor ID
- 14-AOI-11
- Conditions
- Pulmonary Embolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosémide | Experimental | Drug: FurosemideFurosemide: 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." |
| NaCl 9% isotonic | Active comparator | Drug: NaCl 9% isotonicInfusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized in the first 24 hours of a serious EP normotensive formally diagnosed (by a chest CT)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: diuretic vascular fillingfurosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc | Drug | Furosémide |
| NaCl 9% isotonicAlso: fluid replacementnormal saline 500 cc / 4 hours and 1 L / 24 hours | Drug | NaCl 9% isotonic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 35381867Ferrari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emile FERRARI principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and NaCl 9% isotonic in people with Pulmonary Embolism, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time normalization hours Troponin Ic. (time frame: participants will be followed for the duration of hospital stay, an expected average of 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.