VExUS in Patients With Acute Heart Failure

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06397404
• Other study ID #: SS-DCFUD-02-2023
• Status: Completed
• Start date: May 18, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: March 2024
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• Venous excess ultrasound score (VExUS) protocol
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of acute kidney injury (AKI)	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.	During 7 days of hospital stay
Secondary	In-hospital mortality	Death from any cause, whichever came first	During patient's hospital stay (up to 14 days)
Secondary	Change in spot urine sodium content <50 mmol/l	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.	1 hour after first standard intravenous loop diuretic administration after patient's admission.
Secondary	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)	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.	6 hours after first intravenous furosemide administration

External Links

•   ACC Middle East & Eastern Mediterranean 2023, Athens, Greece, poster presentation. "Assessment of intrarenal venous flow can predict acute kidney injury in patients with acute heart failure." Sofia Sovetova
•   Sovetova, S, Andreev, D, Shchekochikhin, D. IMPACT OF RENAL BLOOD FLOW PATTERNS ON DIURETIC RESPONSE IN PATIENTS WITH ACUTE DECOMPENSATION OF HEART FAILURE. J Am Coll Cardiol. 2024 Apr, 83 (13_Supplement) 335