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Trials / Completed

CompletedNCT06397404

VExUS in Patients With Acute Heart Failure

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
I.M. Sechenov First Moscow State Medical University · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTVenous excess ultrasound score (VExUS) protocolAll 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.

Timeline

Start date
2023-05-18
Primary completion
2023-11-25
Completion
2023-12-25
First posted
2024-05-02
Last updated
2024-05-20

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT06397404. Inclusion in this directory is not an endorsement.