LUS in Acute Heart Failure Therapeutic Adaptation (EPPICA)

November 12, 2020 updated by: University Hospital, Grenoble

Interest of Lung Ultrasound (LUS) in Therapeutic Adaptation of Patients Hospitalized in Medical Department for Acute Heart Failure (AHF).

Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

EPPICA is an observational and prospective cohort study. The study goal is to evaluate LUS aspect evolution according to diuretics dosage in patients hospitalized for acute heart failure.

Study Type

Observational

Enrollment (Anticipated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged over 18, hospitalized from the emergency department in the medical department for acute heart failure.

Description

Inclusion Criteria:

  • Acute heart failure diagnosed by a senior physician in the medical department, with a confirmation of a second senior physician.
  • Hospitalised in the medical department.
  • No objection from the patient of his trusted person.

Exclusion Criteria:

  • Administrative supervision or deprived of their liberty
  • Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis)
  • Chronically dialysed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute heart failure
Patients hospitalized for acute heart failure in medical department.
Other: Lung ultrasound
We will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound aspect according to diuretics dosage evolution.
Time Frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days).
B-lines number on LUS
LUS will be performed daily during the whole hospitalisation length (on average 7 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound aspect according to clinical signs of acute heart failure (crackling auscultation or lower limbs edema)
Time Frame: LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
B-lines number on LUS
LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
Lung ultrasound aspect according to acute kidney injury (based on plasmatic creatinine levels).
Time Frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days). Plasmatic creatinine measure will be performed at least weekly.
B-lines number on LUS
LUS will be performed daily during the whole hospitalisation length (on average 7 days). Plasmatic creatinine measure will be performed at least weekly.
Lung ultrasound aspect according to early prognosis (re-hospitalisation or mortality within 30 days after discharge)
Time Frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days). Patient will be called 30 days after discharge.
B-lines number on LUS
LUS will be performed daily during the whole hospitalisation length (on average 7 days). Patient will be called 30 days after discharge.
Feasibility of daily LUS in medical department.
Time Frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Number of LUS performed compared to number of hospitalisation days.
LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Interest of LUS compared to clinical examination at discharge.
Time Frame: LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
B-lines at discharge compared to clinical signs of acute heart failure.
LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Perrine Dumanoir, Doctor, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.328
  • 2020-A02413-36 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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