Boston Medical Center Ultrasound Decongestion Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Boston Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 90-day hospital readmission rate
Study Overview
Brief Summary
The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload/decompensated heart failure.
Detailed Description
This superiority randomized clinical trial will compare the therapeutic intervention of five-point ultrasound-guided diuresis with standard of care diuresis for decompensated heart failure. Participants with heart failure exacerbation will be randomly allocated in a 1:1 ratio using heart failure patient lists, by a heart failure physician in the emergency department or on the floors. Similarly, patients will be randomly selected in a 1:1 ratio in the outpatient heart failure infusion clinic when seen for heart failure exacerbation by a heart failure physician. The study population will be generally stable and can be inpatient or outpatient.
The primary objective of the study is to evaluate and compare the efficacy of diuresis when driven by standard of care or five-point ultrasound to guide clinical decision making by assessing 30-day hospital readmission rate in patients undergoing standard of care vs ultrasound assisted diuresis.
The specific aims are:
Aim 1. To measure and compare changes in ultrasonographic parameters (ultrasound Doppler profiles, VExUS scores) through the course of a HF hospitalization for decongestion for acute decompensated HF admission.
Aim 2. To compare 30-day and 90-day HF readmission rates between randomized patients with HF admission comparing SOC to VExUS-guided decongestion strategy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Participants in both arms will be blinded as they will receive VExUS scan throughout their admission. For the control arm, the treatment team (clinicians) will be blinded to the VExUS scores and will conduct SOC with the patient for the course of their admission. All investigator sonographers performing the VExUS scans will be blinded to arm assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with a primary diagnosis of acute on chronic decompensated heart failure who is admitted to inpatient or presents to the outpatient Boston Medical Center (BMC) Heart Failure Infusion clinic for decongestion treatment.
- •Willing and able to receive short abdominal and thoracic ultrasounds throughout hospitalization
- •Patients with right and/or left ventricular failure
Exclusion Criteria
- •Hemodynamic instability defined as systolic blood pressure <85 mmHg or mean arterial pressure <60 mm Hg for greater than 24 hours duration
- •Abdominal surgery in the past 1 month
- •Significant acute or chronic liver disease
- •End stage renal disease on dialysis
- •Advanced chronic kidney disease (CKD) [Stage V CKD with glomerular filtration rate (GFR) <15] to exclude renal vein doppler ultrasound
- •Severe acute kidney injury (AKI) or requiring renal replacement therapy
- •Known abdominal thrombus in the inferior vena cava (IVC) or portal vein
- •Acute myocarditis
- •Acute valvular disease
- •Acute type 1 myocardial infarction
- •Medical condition precluding abdominal ultrasound due to significant discomfort or pain
- •Adults not able to provide consent (a simple teach back method of key aspects discussed in consent form will be utilized to verify if patient is able to adequately provide informed consent)
Arms & Interventions
Five-point ultrasound guided diuresis
Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.
Intervention: Five-point ultrasound (Device)
Five-point ultrasound guided diuresis
Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.
Intervention: Standard of care (Other)
Standard of care guided diuresis
Participants randomized to this study arm will have their diuresis clinically guided by standard of care. They will also have five point ultrasound but the results will not inform their diuresis.
Intervention: Five-point ultrasound (Device)
Standard of care guided diuresis
Participants randomized to this study arm will have their diuresis clinically guided by standard of care. They will also have five point ultrasound but the results will not inform their diuresis.
Intervention: Standard of care (Other)
Outcomes
Primary Outcomes
90-day hospital readmission rate
Time Frame: 90 days after discharge (on average 3-10 days)
The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records.
Worsening renal failure/acute renal injury
Time Frame: admission to 4 weeks post discharge (on average 3-10 days)
This outcome is defined by an increase in 25% of serum creatinine or serum cystatin C from the time of admission to 4 weeks post discharge. It will be abstracted from the participants' electronic medical records.
VExUS Doppler profiles and scores
Time Frame: At admission, At discharge (on average 3-10 days)
The range of VExUS profiles and scores to guide clinicians with heart failure diuresis are: No congestion (normal inferior vena cava), Minimal congestion (0 or 1 abnormal doppler patterns). Mild congestion (2 abnormal patterns and portal vein pulsatility fraction \[PVPF\] less than 30%), Moderate congestion (2 abnormal patterns and PVPF between 30 and 50%), Severe congestion (2 abnormal patterns and PVPF more than 50%).
30-day hospital readmission rate
Time Frame: 30 days after discharge (on average 3-10 days)
The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records.
Secondary Outcomes
- All-cause mortality(30 days, 90 days)
- Need for renal replacement therapy(30 days, 90 days)
- Hospital length-of-stay for decompensated heart failure(At hospital discharge (on average 3-10 days))
- 30-day HF readmission rate(30 days post discharge (on average 3-10 days))