POCUS-Guided Diuresis for Decompensated Heart Failure

NCT06921603 | Recruiting

• 2 other identifiers: STUDY2409009225POST1361664
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Heart Decompensation, Acute; Acute Kidney Injuries

Keywords

heart failure; point-of-care-ultrasound; readmission; acute kidney injury

Outcome Measures

Primary Outcomes (2)

• 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.

  From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first.

• 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)

  From baseline to hospital discharge and up to 30 days post-discharge (if readmitted).

Secondary Outcomes (4)

• 30-Day Mortality

  From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.

• Length of Hospital Stay

  From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.

• Renal Function at Discharge

  From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.

• Adherence to POCUS-Based Recommendations

  From date of hospital admission until date of hospital discharge, assessed up to 60 days.

Study Arms (2)

POCUS-assessed diuretic management

EXPERIMENTAL

Participants 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.

Other: POCUS-Assessed Diuretic Management

Furosemide (Standard Diuretic) Treatment

ACTIVE COMPARATOR

Participants 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.

Other: Furosemide (Standard Diuretic) Treatment

Interventions

Furosemide (Standard Diuretic) Treatment OTHER

Participants 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.

Furosemide (Standard Diuretic) Treatment

POCUS-Assessed Diuretic Management OTHER

POCUS 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.

POCUS-assessed diuretic management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• These criteria ensure that participants are appropriately selected for the study and are likely to benefit from POCUS-guided diuretic management.

You may not qualify if:

• 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.
• Advanced Cancer: Patients with metastatic cancer will be excluded.
• Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
• End stage chronic kidney disease
• Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
• Inotropic Support: Patients requiring inotropic support at the time of enrollment will be excluded, as they represent a more severe heart failure profile that may not be suitable for this trial.

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Heart Association: collaborator

Study Sites (5)

UPMC East

Pittsburgh, Pennsylvania, 15146, United States

NOT YET RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

NOT YET RECRUITING

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

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MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury

Interventions

Furosemide; Therapeutics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• John J Pacella, MD

  University of Pittsburgh Medical Center (UPMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John J Pacella, MD

CONTACT

4127805529; pacellajj@upmc.edu

Benay Ozbay, MD

CONTACT

4124502774; benayozbay@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Participants are randomized into two groups: a POCUS-assessed group and a standard care control group. Each group follows separate management protocols during the study.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: June 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain accessible for 5 years thereafter.
• Access Criteria: Access to the dataset will be granted to researchers upon submission of a formal request, outlining the study objectives and analysis plan. Approval will be contingent upon compliance with ethical guidelines, data privacy regulations, and institutional review board (IRB) requirements. Researchers will be required to sign a data-sharing agreement (DSA) before receiving access.

Locations

US (5)