drugset / Trial / NCT02531581

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

NCT02531581

Phase 4 Completed 60 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-12-23
Primary completion
2020-04-09
Completion
2020-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 40 mg Intravenous

Indications