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This study will evaluate whether using bedside ultrasound (also called Point-of-Care Ultrasound or POCUS) can help improve the care of hospitalized patients with decompensated heart failure. Patients will be randomly assigned to two groups: one group will receive ultrasound-guided assessments, and the other group will receive standard clinical evaluations. Researchers will compare the hospital length of stay between the two groups. Ultrasound is a non-invasive, safe, and painless imaging tool. The goal of the study is to find out if ultrasound guidance can lead to shorter hospitalizations and better care for patients with heart failure.
This clinical trial aims to determine whether the use of bedside ultrasound (also called Point-of-Care Ultrasound, or POCUS) can improve the management of patients hospitalized with decompensated heart failure. Traditional methods for assessing heart failure patients rely heavily on physical examination and imaging tests such as chest X-rays, which may not always accurately reflect a patient's volume status. POCUS provides real-time information at the bedside, allowing clinicians to assess lung congestion and venous volume status quickly and non-invasively.
Participants in this study will be randomly assigned to one of two groups. The intervention group will undergo POCUS assessments of the lungs and inferior vena cava (IVC) twice during their hospitalization: once within 24 hours of admission and once before discharge. The control group will receive standard clinical care without ultrasound guidance. All participants' clinical information, including length of hospital stay, treatments administered, and 30-day readmission status, will be collected and analyzed.
The primary objective is to determine whether POCUS-guided management leads to a reduction in hospital length of stay. Secondary objectives include evaluating whether ultrasound guidance affects 30-day readmission rates and diuretic therapy adjustments. The study is expected to enroll approximately 66 patients.
This research may help establish whether POCUS can be incorporated into standard care practices for hospitalized heart failure patients, potentially leading to better outcomes and more efficient use of hospital resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POCUS-Guided Evaluation Group | Experimental | Participants in this group will receive bedside Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) twice during hospitalization, once within 24 hours of admission and once prior to discharge. Ultrasound findings will be used to guide fluid management decisions. |
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| Standard Clinical Evaluation Group | No Intervention | Participants in this group will receive standard clinical care without bedside ultrasound guidance. Clinical evaluation and management will be based on physical examination, chest X-rays, laboratory results, and physician judgment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Ultrasound (POCUS) | Device | Participants assigned to this group will receive Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) during their hospital stay. The ultrasound will be performed twice: once within 24 hours of hospital admission and once prior to hospital discharge. The POCUS findings will be used to guide clinical management decisions regarding fluid status and decongestion therapy in patients with decompensated heart failure. The procedure is non-invasive, radiation-free, and performed at the bedside. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay (LOS) | Hospital Length of Stay (LOS) will be measured as the number of days from hospital admission to discharge decision. LOS will be compared between the POCUS-guided group and the standard care group. | From the date of hospital admission to the date of discharge order, assessed up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day Hospital Readmission Rate | The proportion of patients readmitted to any hospital for any cause within 30 days after discharge will be recorded and compared between the POCUS-guided group and the standard care group. | Within 30 days after hospital discharge |
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Inclusion Criteria:
Adults aged 18 years and older.
Hospitalized with a primary diagnosis of decompensated heart failure (left, right, or biventricular).
Evidence of volume overload or congestion based on Framingham criteria, clinical examination, elevated proBNP (>1000 pg/mL), or chest X-ray showing pulmonary edema.
Ability to undergo bedside ultrasound evaluation (POCUS) as clinically feasible.
Able to provide informed consent.
Exclusion Criteria:
Age under 18 years.
Pregnant or breastfeeding women.
Terminal illness with life expectancy < 30 days.
Inability to obtain ultrasound images due to body habitus or other technical reasons.
Enrollment in another interventional clinical trial that could interfere with the outcomes of this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GUILLERMO IZQUIERDO PRETEL, MD | Contact | 13058128099 | gizquier@fiu.edu | |
| FIU TEAM F | Contact | 3055101801 | sacramento1624@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| GUILLERMO IZQUIERDO PRETEL, MD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136 | United States |
I am running a single-center investigator-initiated study. I am not creating a formal public repository for the individual patient data.
At this stage, I am focused on analyzing your results internally (not distributing patient-level data to outside researchers).
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Participants will be randomized in a 1:1 ratio to either a Point-of-Care Ultrasound (POCUS)-guided evaluation group or a standard clinical evaluation group. Participants in each group will remain in their assigned arm throughout the duration of their hospital stay. The study is designed as a parallel assignment model without crossover between groups.
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|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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