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

Not Applicable

Completed

• Conditions: Fluid Overload; Cardiorenal Syndrome; Decompensated Heart Failure; Ultrasound Therapy; Complications; Acute Kidney Injury
• Interventions: Other: Control group; Diagnostic Test: Vexus

• Registration Number: NCT05927285
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-20
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-26
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-22
• Status Verified: 2023-07
• Study First Posted: 2023-07-03
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	Control group	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.
VeXUS group	Vexus	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.

Primary Outcome Measures

Name	Time	Method
Kidney Function Recovery	from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days	Assess Kidney Function Recovery evaluated as serum Creatinine return to baseline value

Secondary Outcome Measures

Name	Time	Method
vascular decongestion during hospitalization	from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days	Decongestion was defined as the following criteria: absence of peripheral edema, absence of orthopnea, no jugular ingurgitation, decreased or absent dyspnea, \>30% decrease in BNP, CA 125 \<35 ug/dL, chest X-ray without evidence of congestion, and less than days of hospitalization, mortality, changes in brain natriuretic peptide (BNP) and CA-125

Trial Locations

Locations (1)

HCG; 🇲🇽 Guadalajara, Jalisco, Mexico