POCUS-Guided Diuresis for Decompensated Heart Failure
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT06921603
- Status
- Recruiting
Conditions
- Acute Kidney Injuries
- Heart Decompensation, Acute
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Furosemide (Standard Diuretic) Treatment — OTHERParticipants 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 — OTHERPOCUS 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.
Study Details
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.
Key Dates
- Start date
- Jun 29, 2025
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 588 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: POCUS-assessed diuretic managementParticipants in this group will undergo daily POCUS imaging to assess volume status. The right internal jugular vein (RIJV) Distensibility Index (DI) will be measured and shared with the clinical team to guide diuretic (intravenous furosemide) management. However, all treatment decisions will be made at the discretion of the treating physicians.
- Active Comparator: Furosemide (Standard Diuretic) TreatmentParticipants in this group will receive intravenous furosemide (standard diuretic) treatment, as part of their routine care, based on clinical evaluation. POCUS imaging will be performed daily for research only, and findings will not be shared with the clinical team. Treatment decisions will follow usual care protocols.
Primary Outcome Measure
30-Day Readmission Rate in Acute Decompensated Heart Failure (ADHF) Patients [ Time Frame: From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first. ]
Central Contacts
- John J Pacella, MD4127805529
- Benay Ozbay, MD4124502774
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | John Pacella, MD (PRINCIPAL_INVESTIGATOR) Benay Ozbay, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC East | Pittsburgh | Pennsylvania | 15146 | Hamit Mahamat Chahata, MD (SUB_INVESTIGATOR) |
| UPMC Mercy | Pittsburgh | Pennsylvania | 15219 | Vanessa Mutch, MD (SUB_INVESTIGATOR) |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | Benay Ozbay, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Shadyside | Pittsburgh | Pennsylvania | 15232 | Adam Sohnen, MD (SUB_INVESTIGATOR) James Ma, MD (SUB_INVESTIGATOR) |