Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunctio… (NCT02531581) | Clinical Trial Compass
CompletedPhase 4
Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive
France60 participantsStarted 2015-12-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time normalization hours Troponin Ic.
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 12 hours