Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1

Hospital Civil de Guadalajara

Status: Completed

Conditions: Cardiorenal Syndrome; Decompensated Heart Failure; Acute Kidney Injury; Ultrasound Therapy; Complications; Fluid Overload

Treatments: Other: Control group; Diagnostic Test: Vexus

Study type: Interventional

Funder types: Other

Identifiers

NCT05927285

HCG/CEI-0836/22

Details and patient eligibility

About

During cardiorenal syndrome type 1 (CRS1) vascular congestion is the major contributor to worsening renal function, but promoting decongestion with routine clinical evaluation is ineffective in some patients. The venous evaluation by ultrasound (VExUS) may optimize its management when evaluating for improvement in kidney function and other metrics related to decongestion.

Full description

Background: In cardiorenal syndrome type 1 (CRS1) vascular congestion is a common complication, the Venus Evaluation by Ultrasound System (VExUS) could guide decongestion effectively and thereby improve kidney function outcomes.

Methods: In this double-blind randomized clinical trial, patients with CRS1 were randomized to guide decongestion with VExUS compared to usual clinical evaluation. The primary and secondary endpoint was to assess kidney function recovery (KFR), days of hospitalization, mortality, changes in brain natriuretic peptide (BNP) and CA-125. Protocol register HCG/CEI-0836/22.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiorenal Syndrome type 1

Exclusion criteria

• kidney transplantation, chronic kidney disease (CKD) grade 4 or 5, dialysis and pregnancy. CKD was defined according to the KDIGO guidelines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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140 participants in 2 patient groups

VeXUS group

Experimental group

Description:

The VExUS group was considered the intervention group, where in addition to all the above, the decision for decongestant treatment was guided by the VExUS score until reaching a score that VExUS considered noncongestive, which was grade 0.

Treatment:

Diagnostic Test: Vexus

Control group

Active Comparator group

Description:

The control group is considered the conventional approach, where the treatment was guided by improvement in clinical data, imaging, or laboratory studies during the daily evaluation until categorized as decongested.

Treatment:

Other: Control group