NCT05871138

Brief Summary

prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

March 17, 2023

Last Update Submit

May 13, 2023

Conditions

Keywords

Delta-lus scoreheart failure

Outcome Measures

Primary Outcomes (2)

  • Delta lus

    The primary outcome evaluate the contribution of the variation of the LUS score performed at the time of admission (LUS1) and at discharge (LUS2) in predicting the clinical course of patients admitted for acute cardiac

    30 days

  • Readmission

    Readmission

    30 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective observational study that will be conducted in the emergency department of CHU Fattouma Bourguiba Monastir over a period from March 2023 to December 2023. Will be included in this study patients aged over 18 years, hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit). These patients will be contacted after one month of their discharge from the hospital

You may qualify if:

  • Patients aged over 18 years,
  • Patients hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit).

You may not qualify if:

  • Age less than 18 years
  • Dyspnea of non-cardiac etiology (cause: pulmonary, traumatic, toxic...)
  • Altered state of consciousness (Glasgow score\<14)
  • Hemodynamic instability: presence of peripheral signs of shock, use of vasoactive drugs
  • Mechanical ventilation from the outset
  • Cardiorespiratory arrest
  • Inability to give consent to the study
  • Missing one of two ultrasound examinations
  • Unable to make telephone contact after one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Semir Nouira

Monastir, Monastur, 5000, Tunisia

RECRUITING

Emergency Departement

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

EmergenciesHeart Failure

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Nouira Semir, Pr

    University of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira Semir, Pr

CONTACT

Bel Hadj Ali Khaoula, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical proffesor

Study Record Dates

First Submitted

March 17, 2023

First Posted

May 23, 2023

Study Start

March 30, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations