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NCT Number: NCT06397404

VExUS in Patients With Acute Heart Failure

The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City clinical hospital named after S. S. Yudin, Moscow City Health Department, Moscow, Russian Federation

Moscow, 115446, Russia

About this study

It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).

This prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate <0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine >26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content <50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml

Exclusion criteria

  • Chronic renal replacement therapy or glomerular filtration rate < 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)
  • Cirrhosis with portal hypertension
  • Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction
  • Pulmonary embolism
  • Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
  • Endotracheal intubation at the time of admission
  • Pregnancy or breastfeeding
  • Aortic dissection
  • Active cancer
  • Neurological or mental disease during exacerbation
  • Refusal to sign an informed consent form, inadequate acoustic window

Treatment and study plan

Venous excess ultrasound score (VExUS) protocol

Diagnostic Test

All patients upon admission undergo ultrasound assessment of diameter and collapsibility of the inferior vena cava, hepatic vein Doppler, portal vein Doppler, intra-renal venous Doppler.

Primary outcomes

  1. Development of acute kidney injury (AKI)

    Time frame: During 7 days of hospital stay

    Assessment of patient's serum creatinine at admission, in 48 hours, at day 7, and calculation of the amount of urine output in the first 6 h after the administration of a loop diuretic.

Secondary outcomes

  1. In-hospital mortality

    Time frame: During patient's hospital stay (up to 14 days)

    Death from any cause, whichever came first

  2. Change in spot urine sodium content <50 mmol/l

    Time frame: 1 hour after first standard intravenous loop diuretic administration after patient's admission.

    Sodium concentration in a spot urine sample is assessed in 1 hour after first intravenous loop diuretic administration. Reduction of natriuretic response in the face of congestion with volume overload with spot urine sodium content <50 mEq/L generally identifies a patient with an insufficient diuretic response.

  3. Development of diuretics resistance (defined as the need to double initial dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents)

    Time frame: 6 hours after first intravenous furosemide administration

    Assessment of diuretic response: patient's urine output (ml/kg/hour) in the first 6 hours and patient's medical record with doses of administered diuretics.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Congestion Assessment Using Venous Excess Ultrasound Score (VExUS) in Patients With Acute Heart Failure

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 2, 2024
Registry last updated
May 20, 2024

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.

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