NCT Number: NCT06921603
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
UPMC East, Pittsburgh, Pennsylvania, United States
Heart failure is a major cause of hospitalization in the United States, affecting over 5 million adults, with 30-day readmission rates as high as 22%. Hospitalizations account for the majority of acute decompensated heart failure (ADHF)-related healthcare costs, and institutions that care for lower-income populations face added pressure under value-based payment models such as the Hospital Readmission Reduction Program (HRRP).
ADHF is characterized by elevated cardiac filling pressures and systemic congestion. Traditional clinical assessments, such as physical examination, chest radiography, and jugular venous pressure (JVP) evaluation, are often limited by low accuracy and high interobserver variability. Residual congestion at discharge is a key predictor of readmission and contributes to complications like acute kidney injury (AKI), which can occur in up to 20% of ADHF hospitalizations and is associated with increased mortality, longer length of stay, and higher healthcare costs (up to $80,400 per patient).
Point-of-care ultrasound (POCUS) has emerged as a valuable bedside tool for non-invasive, real-time volume assessment. This study focuses on a novel application of POCUS that uses the right internal jugular vein (RIJV) to estimate right atrial pressure (RAP). By measuring the cross-sectional area (CSA) of the RIJV during rest and the Valsalva maneuver, the Distensibility Index (DI) can be calculated. A DI ≥66% is associated with low RAP (≤12 mmHg), while lower values indicate persistent venous congestion.
Previous studies support the utility of this method. In a right heart catheterization cohort (n=67), DI predicted elevated RAP with 87% positive predictive value. In a prospective observational cohort (n=274), a DI ≥66% at discharge was associated with a 91.1% negative predictive value for avoiding early readmission. Patients with elevated RAP at discharge were 3.5 times more likely to be readmitted within 30 days.
This study introduces POCUS-guided diuretic management in hospitalized ADHF patients. The ultrasound-derived DI will be used to inform decisions regarding diuretic therapy and discharge readiness. All ultrasound operators will receive standardized training to ensure reproducibility of measurements. Clinician adherence to POCUS-guided recommendations will be monitored, and structured feedback will be obtained to assess usability.
By enhancing volume status assessment, this approach aims to improve decongestion strategies, reduce 30-day readmissions, and prevent kidney injury. If successful, this method could be integrated into routine clinical workflows, especially in settings where advanced imaging resources are limited. The study may inform future clinical guidelines and support more individualized, equitable care for patients with heart failure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
List the inclusion criteria:
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:
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 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.
Time frame: From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first.
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 baseline to hospital discharge and up to 30 days post-discharge (if readmitted).
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:
Outcome Type: Binary (Yes/No)
Time frame: From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.
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 the date of hospital admission until the date of hospital discharge, assessed up to 60 days.
The duration of hospitalization in days, measured for both groups.
Time frame: From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.
Change in eGFR (mL/min/1.73m²) from baseline to discharge to assess kidney function.
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 60 days.
Percentage of cases in the POCUS-Assessed Group where clinicians followed POCUS-based recommendations for diuretic management.
Contact information is provided by the study sponsor or research team.
Benay Ozbay, MD
CONTACT
John J Pacella, MD
CONTACT
University of Pittsburgh
Other
Point-of-Care Ultrasound-Guided Diuresis for Acute Decompensated Heart Failure to Reduce 30-Day Readmissions and Acute Kidney Injury
Acronym: POCUSHF-GD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03210909
Cardiovascular Diseases, Heart Decompensation, Acute
Madison, Wisconsin, United States
View Trial DetailsNCT02932969
Cardiovascular Diseases, Heart Decompensation, Acute
Cypress, California, United States
View Trial DetailsNCT07273838
Acute Kidney Injury, Cardiovascular Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT07445997
Acute Kidney Injuries, Acute Kidney Injury
Bursa, Turkey (Türkiye)
View Trial Details