POCUS-Guided Diuresis for Decompensated Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
Heart failure occurs when the heart cannot pump blood effectively, leading to fluid buildup in the body. This can cause problems such as difficulty breathing, swelling, and extreme tiredness. In severe cases, these symptoms worsen to the point where hospitalization is required. Unfortunately, many patients with severe heart failure are readmitted to the hospital within 30 days after discharge, which is both physically and emotionally challenging for patients and places a significant financial burden on individuals and the healthcare system.
Although symptoms such as difficulty breathing and swelling may improve during the hospital stay, some patients are discharged with excess fluid remaining in their bodies. This retained fluid often causes symptoms to worsen, leading to subsequent hospital readmissions. Inadequate management of fluid levels can also harm the kidneys, further complicating the patient's condition.
This study aims to improve care for heart failure patients by utilizing a simple, non-invasive tool to assess fluid levels more accurately at the bedside. The tool measures the size of a large blood vessel in the neck, providing key information about the pressure inside the heart. This information enables clinicians to determine the appropriate amount of medication needed to remove just the right amount of fluid. Properly managing fluid levels can help prevent kidney damage and improve overall patient outcomes.
The primary goal of this study is to evaluate whether this tool can reduce the number of patients readmitted to the hospital within 30 days of discharge. A secondary goal is to determine whether the tool can help protect kidney function by allowing for better fluid management. If successful, this approach has the potential to help heart failure patients stay healthier, reduce hospital visits, and lower healthcare costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Patients must be 18 years or older.
Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
POCUS Measurement: Must have an abnormal right internal jugular vein (RIJV) distensibility index (DI) of <66% on point-of-care ultrasound (POCUS) at the time of admission.
Disqualifiers
Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
Anatomical Incompatibilities: Excludes patients with RIJV or superior vena cava thrombus, congenital heart disease, or severe tricuspid regurgitation, as these conditions may impair accurate POCUS measurements.
Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Furosemide (Standard Diuretic) Treatment
Other interventionParticipants in this group will receive intravenous furosemide as part of their routine care, based on clinical assessments including symptoms, physical examination. Daily POCUS imaging will be performed for research purposes; however, the findings will not be shared with the treating clinical team. Fluid management decisions and discharge planning will follow usual care protocols, without additional imaging-based guidance.
POCUS-Assessed Diuretic Management
Other interventionPOCUS will be used to provide objective, non-invasive assessments of fluid status by measuring right internal jugular vein (RIJV) cross-sectional area (CSA) and calculating the Distensibility Index (DI). This information will be shared with the treating clinical team as an additional tool for fluid management. However, all final decisions regarding diuretic therapy will be made at the discretion of the treating physicians.
Treatment groups
588 Participants
are divided into 2 treatment groupsGroup A: POCUS-assessed diuretic managementExperimental treatment 1 intervention
Group B: Furosemide (Standard Diuretic) TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-Day Readmission Rate in Acute Decompensated Heart Failure (ADHF) Patients
The percentage of participants readmitted to the hospital within 30 days of discharge for heart failure-related issues. The outcome compares the readmission rates between the POCUS-assessed diuretic management group and the standard care group.
Time frame
From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first.2
Incidence of Acute Kidney Injury (AKI)
The percentage of participants who develop acute kidney injury (AKI) during hospitalization or within 30 days post-discharge (if readmitted). Definition: AKI will be defined using the Acute Kidney Injury Network (AKIN) criteria: * Increase in serum creatinine by ≥0.3 mg/dL within 48 hours OR * Increase in serum creatinine by ≥50% from baseline OR * Reduced urine output (\<0.5 mL/kg/hr for ≥6 hours). Outcome Type: Binary (Yes/No)
Time frame
From baseline to hospital discharge and up to 30 days post-discharge (if readmitted).Secondary outcomes
1
30-Day Mortality
The percentage of participants who die within 30 days of discharge. This outcome compares mortality rates between the POCUS-assessed and standard care groups.
Time frame
From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.2
Length of Hospital Stay
The duration of hospitalization in days, measured for both groups.
Time frame
From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.3
Renal Function at Discharge
Change in eGFR (mL/min/1.73m²) from baseline to discharge to assess kidney function.
Time frame
From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.4
Adherence to POCUS-Based Recommendations
Percentage of cases in the POCUS-Assessed Group where clinicians followed POCUS-based recommendations for diuretic management.
Time frame
From date of hospital admission until date of hospital discharge, assessed up to 60 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov