Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397404
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-04-06
Brief Title:
VExUS in Patients With Acute Heart Failure
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
Congestion Assessment Using Venous Excess Ultrasound Score VExUS in Patients With Acute Heart Failure
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 mlkghour for 6 hours and an increase of serum creatinine 26 µmoll 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 mmoll 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
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 05 mlkghour for 6 hours and an increase of serum creatinine 26 µmoll 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 mmoll 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None