Boston Medical Center Ultrasound Decongestion Study in Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Five-point ultrasound
DeviceIn-person study visits will be done on initial evaluation and then at least every 48 hours, during which serial five-point ultrasound will be performed to assess venous congestion. Each visit will not be at strict intervals; a reasonable time window is every 48 hours +/- 12 hours. Ultrasound may be performed more frequently if clinically indicated. During these visits or between them, ultrasound of the heart may additionally be performed. Each visit will last between 10 and 60 minutes.
Standard of care
Other interventionStandard of care will most likely include radiographic investigations (chest X-ray, chest CT), laboratory evaluation (complete blood counts, metabolic panel, B-type natriuretic peptide, high-sensitivity troponin, electrolytes, renal function, urine testing), volume status, and cardiopulmonary physical exam.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Five-point ultrasound guided diuresisExperimental treatment 2 interventions
Group B: Standard of care guided diuresisActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
VExUS Doppler profiles and scores
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%).
Time frame
At admission, At discharge (on average 3-10 days)2
30-day hospital readmission rate
The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records.
Time frame
30 days after discharge (on average 3-10 days)3
90-day hospital readmission rate
The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records.
Time frame
90 days after discharge (on average 3-10 days)4
Worsening renal failure/acute renal injury
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.
Time frame
admission to 4 weeks post discharge (on average 3-10 days)Secondary outcomes
1
Hospital length-of-stay for decompensated heart failure
The total number of days hospitalized for decompensated heart failure will be abstracted from the participants' electronic medical records.
Time frame
At hospital discharge (on average 3-10 days)2
30-day HF readmission rate
The number of readmissions within 30-days of hospital discharge that are specifically due to HF
Time frame
30 days post discharge (on average 3-10 days)3
All-cause mortality
All-cause mortality will be abstracted from the participants' electronic medical records.
Time frame
30 days, 90 days4
Need for renal replacement therapy
The need for renal replacement therapy will be abstracted from the participants' electronic medical records.
Time frame
30 days, 90 daysSponsors and contacts
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Source ClinicalTrials.gov
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