EmergenciesDeltalusNCT05871138
Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure
An observational study of Emergencies and Acute Heart Failure, run by University of Monastir at 2 sites in Tunisia.
Trial summary
prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Emergencies, Acute Heart Failure
- How many people
- 500 participants
- Where
- 2 sitesTunisia
- Study dates
- 30 Mar 2023to 30 Dec 2023
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Inability to give consent to the study
- Missing one of two ultrasound examinations
- Unable to make telephone contact after one month.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 2 recruiting
- Recruiting
Semir Nouira
Monastir, Monastur, 5000
Semir Nouira, +21673106000, semir.nouira.urg@gmail.com
+21673106046
- Recruiting
Emergency Departement
Monastir, 5000
Semir Nouira, professor, 73 106 085 ext. 216, semir.nouira@rns.tn
kouraichi cyrine, MD, 55598213 ext. 216, cyrinekouraichi@hotmail.com
About this study
Official title: Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure Within 30 Days of Discharge
prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.
Read the detailed description
The aim of our study is to 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 decompensation 30 days after discharge.
Delta LUS score=((LUS2-LUS1) *100)/LUS1
- Conditions
- Emergencies, Acute Heart Failure
- Keywords
- Delta-lus score, heart failure
- Medical subject headings
- Emergencies, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Readmission
Readmission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start30 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871138
- Sponsor's protocol ID
- Delta- LUS
- Acronym
- Deltalus
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure Within 30 Days of Discharge
- ClinicalTrials.gov ID
- NCT05871138
- Acronym / sponsor ID
- Deltalus / Delta- LUS
- Conditions
- Emergencies, Acute Heart Failure
- Keywords
- Delta-lus score, heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.
Detailed description
The aim of our study is to 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 decompensation 30 days after discharge.
Delta LUS score=((LUS2-LUS1) *100)/LUS1
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta lus
Time frame: 30 days
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
Readmission
Time frame: 30 days
Readmission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Semir, Pr principal investigator
University of Monastir
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Acute Heart Failure, run by University of Monastir at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nouira Semir, Pr (73106046 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta lus (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.