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

NCT02531581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Furosemide

furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output \<500cc

DRUG

NaCl 9% isotonic

normal saline 500 cc / 4 hours and 1 L / 24 hours

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Emile FERRARI · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531581 on ClinicalTrials.gov