The use of ultrasound imaging to estimate fluid status to guide the treatment of patients hospitalised with heart failure
| ISRCTN | ISRCTN85160756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85160756 |
- Submission date
- 03/07/2021
- Registration date
- 31/08/2021
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Point of care bedside ultrasound (US) has been of great use in diagnosing and monitoring patients hospitalized with heart failure. Some studies have shown that the use of lung ultrasound (LU) is a good strategy for diagnosing and monitoring the fluid status of the lung in patients with heart failure to guide diuretic treatment to facilitate recovery and to minimize the risk of hospital readmission. This study aims to find out whether LU-guided diuretic treatment reduces the length of hospital stay and 90-day re-admission rate of patients hospitalized with heart failure, in comparison with standard medical treatment.
Who can participate?
Patients aged 18 and over with decompensated heart failure
What does the study involve?
Participants will be assigned to two groups. The first group (intervention) will have bedside lung ultrasound (LU) to guide diuretic therapy and standard medical care for heart failure. The second group (control) will be assessed clinically and will be managed according to the standard medical care for heart failure only.
What are the possible benefits and risks of participating?
There is no definite risk of lung ultrasound. Imaging with ultrasound is generally safe. Patients may benefit by achieving early recovery from their illness with less need for hospital readmission in 90 days.
Where is the study run from?
Sultan Qaboos University Hospital (Oman)
When is the study starting and how long is it expected to run for?
September 2021 to March 2024
Who is funding the study?
The Research Council (Oman)
Who is the main contact?
Dr Abdullah Al-Alawi
Alalawi2@squ.edu.om
Contact information
Scientific
AlMubaila, Sib
Muscat
123
Oman
 ORCID ID |
0000-0003-2077-7186 |
|---|---|
| Phone | +968 (0)95384990 |
| Alalawi2@squ.edu.om |
Public
Ansab, Bawshar
Muscat
123
Oman
| ORCID ID |
0000-0001-7349-8864 |
|---|---|
| Phone | +968 (0)96316695 |
| R2056@resident.omsb.org |
Study information
| Study design | Single-centre open-label interventional controlled clinical trial following a parallel-group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Lung ultrasound-guided diuretic therapy in patients hospitalized with acute decompensated heart failure: an open-label interventional clinical trial |
| Study acronym | LUDT |
| Study hypothesis | Using B-lines to guide diuretics treatment in patients admitted with acute decompensated heart failure (ADHF) can reduce the length of hospital stay (LOS) and 90-days re-admission rate compared to standard treatment. |
| Ethics approval(s) | Approved 26/04/2021, Medical Research Ethics Committee (MREC), College of Medicine and Health Sciences, Sultan Qaboos University, ref: SQU-EC/ 355/2021 |
| Condition | Acute decompensated heart failure |
| Intervention | Eligible participants who are hospitalized with ADHF in general medical wards or high dependency unit at Sultan Qaboos University Hospital (SQUH) will be invited to participate in the study after signing the informed consent. Participants will be assigned to two groups. The first group (intervention) will have bedside lung ultrasound (LU) to guide diuretics therapy and standard medical care of ADHF. The second group (control) will be assessed clinically and will be managed according to the standard medical care of ADHF only. The total duration of the intervention depends on the length of hospital stay and the response to the intervention. Intravenous frusemide will be adjusted targeting a urine output of 500-1000 ml/day along with the resolution of B-lines. Thiazide diuretics will be added according to the patient's symptoms if no contraindication. Once the patient is having less than three B-lines, they will be shifted to oral therapy and discharged home as appropriate. The follow-up period is 90 days from the discharge day. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Length of hospital stay (LOS) days), collected from patient’s electronic medical records, measured from the admission date until the discharge day for each patient |
| Secondary outcome measures | 90-day re-admission rate collected from patient’s electronic medical records and a follow-up phone call at 90 days post-hospital discharge |
| Overall study start date | 01/09/2021 |
| Overall study end date | 03/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 80 |
| Participant inclusion criteria | 1. Patient admitted with ADHF defined as dyspnoea ≥ New York Heart Association (NYHA) III, peripheral oedema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph) 2. Age ≥18 years old 3. Sufficient ultrasound visualization of B-lines |
| Participant exclusion criteria | 1. Chronic dialysis or having chronic kidney disease stage IV based on KDIGO criteria 2. Patients required invasive ventilation 3. Pregnant patients 4. Patients with cardiogenic shock defined as a systolic blood pressure less than 90 mmHg with end-organ hypoperfusion or requiring inotropic support 5. Concomitant acute coronary syndrome 6. Pre-existing chronic lung conditions on home oxygen or non-invasive ventilation (NIV) 7. Concomitant pneumonia 8. Severe valvular disease awaiting definitive intervention |
| Recruitment start date | 19/12/2021 |
| Recruitment end date | 03/01/2024 |
Locations
Countries of recruitment
- Oman
Study participating centre
Muscat
123
Oman
Sponsor information
Hospital/treatment centre
Dr Ali Al Bimani St، Sib
Muscat
123/35
Oman
| Phone | +968 (0)24141103 |
|---|---|
| medicinedept@squ.edu.om | |
| Website | https://www.squh.edu.om/ |
"ROR" |
https://ror.org/049xx5c95 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- TRC
- Location
- Oman
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Abdullah M. Al Alawi (Alalawi2@squ.edu.om). Data will be available for 5 years after concluding the study. The researchers will provide data for scientific purposes only (researchers, medical journals). No data will carry any patient identifications (study codes will be used instead of patients identifications). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/10/2024 | 20/01/2025 | Yes | No |
Editorial Notes
20/01/2025: Publication reference added.
06/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 03/01/2024.
2. The overall trial end date was changed from 30/09/2023 to 03/03/2024.
3. The intention to publish date was changed from 01/12/2023 to 30/12/2024.
4. Total final enrolment added.
14/12/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2021 to 19/12/2021.
2. The recruitment end date was changed from 30/10/2021 to 30/06/2023.
3. The overall trial end date was changed from 31/01/2023 to 30/09/2023.
4. The intention to publish date was changed from 31/03/2023 to 01/12/2023.
31/08/2021: Trial's existence confirmed by Medical Research Ethics Committee (MREC), College of Medicine and Health Sciences, Sultan Qaboos University.
