Recruiting

Fluid Management

Sponsor:

University of Pittsburgh

Code:

NCT06921603

Conditions

Heart Decompensation, Acute

Acute Kidney Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Furosemide (Standard Diuretic) Treatment

POCUS-Assessed Diuretic Management

Study Details

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

Study ID

NCT06921603

Start date

Jun 29, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

List the inclusion criteria:

1. Age: Patients must be 18 years or older.
2. Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
3. Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
4. 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.

List the exclusion criteria:

1. Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
2. 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.
3. Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
4. End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
5. Advanced Cancer: Patients with metastatic cancer will be excluded.
6. Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
7. End stage chronic kidney disease
8. Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
9. 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.

Study Design

Enrollment

588 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: POCUS-assessed diuretic management

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.

active comparator: Furosemide (Standard Diuretic) Treatment

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.

Interventions

Furosemide (Standard Diuretic) Treatment

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.

POCUS-Assessed Diuretic Management

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.

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. ]
  • Incidence of Acute Kidney Injury (AKI) [ Time Frame: From baseline to hospital discharge and up to 30 days post-discharge (if readmitted). ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

John Pacella, MD

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Benay Ozbay, MD

UPMC Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-17.