POCUS-Guided Diuresis for Decompensated Heart Failure

Official title

Point-of-Care Ultrasound-Guided Diuresis for Acute Decompensated Heart Failure to Reduce 30-Day Readmissions and Acute Kidney Injury

Overview

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.

Detailed description

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.

Interventions

• Other 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.
• Other 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 measures

• 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).]

Secondary outcome measures (4)

• 30-Day Mortality [Time frame: From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.]
• Length of Hospital Stay [Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.]
• Renal Function at Discharge [Time frame: From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.]
• Adherence to POCUS-Based Recommendations [Time frame: From date of hospital admission until date of hospital discharge, assessed up to 60 days.]

Eligibility criteria

List the inclusion criteria:

• 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.

List the exclusion criteria:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

United States · 5 centers

• UPMC East — Pittsburgh
• University of Pittsburgh Medical Center — Pittsburgh
• UPMC Presbyterian — Pittsburgh
• UPMC Mercy — Pittsburgh
• UPMC Shadyside — Pittsburgh

Publications

• Kim WR, Biggins SW, Kremers WK, Wiesner RH, Kamath PS, Benson JT, Edwards E, Therneau TM. Hyponatremia and mortality among patients on the liver-transplant waiting list. N Engl J Med. 2008 Sep 4;359(10):1018-26. doi: 10.1056/NEJMoa0801209. PMID 18768945
• Abstract 12544: Point-of-Care Ultrasound Estimation of Right Atrial Pressure Predicts Early Readmission in Patients With Acute Decompensated Heart Failure
• Heldeweg MLA, Jagesar AR, Haaksma ME, Smit JM, Paulus F, Schultz MJ, Tuinman PR. Effects of Lung Ultrasonography-Guided Management on Cumulative Fluid Balance and Other Clinical Outcomes: A Systematic Review. Ultrasound Med Biol. 2021 May;47(5):1163-1171. doi: 10.1016/j.ultrasmedbio.2021.01.024. Epub 2021 Feb 23. PMID 33637390
• Yampolsky S, Kwan A, Cheng S, Kedan I. Point of Care Ultrasound for Diagnosis and Management in Heart Failure: A Targeted Literature Review. POCUS J. 2024 Apr 22;9(1):117-130. doi: 10.24908/pocus.v9i1.16795. eCollection 2024. PMID 38681155
• Chaudhary R, Sukhi A, Simon MA, Villanueva FS, Pacella JJ. Role of Internal Jugular Venous Ultrasound in suspected or confirmed Heart Failure: A Systematic Review. J Card Fail. 2022 Apr;28(4):639-649. doi: 10.1016/j.cardfail.2021.08.009. Epub 2021 Aug 19. PMID 34419599
• Allen LA, Smoyer Tomic KE, Smith DM, Wilson KL, Agodoa I. Rates and predictors of 30-day readmission among commercially insured and Medicaid-enrolled patients hospitalized with systolic heart failure. Circ Heart Fail. 2012 Nov;5(6):672-9. doi: 10.1161/CIRCHEARTFAILURE.112.967356. Epub 2012 Oct 16. PMID 23072736
• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology PMID 35379503
• Njoroge JN, Teerlink JR. Pathophysiology and Therapeutic Approaches to Acute Decompensated Heart Failure. Circ Res. 2021 May 14;128(10):1468-1486. doi: 10.1161/CIRCRESAHA.121.318186. Epub 2021 May 13. PMID 33983837

Identifiers

NCT: NCT06921603 · STUDY24090092 · 25POST1361664

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗