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OpenTrials
Completed

NCT Number: NCT05927285

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

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.

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Key information

Conditions

Cardiorenal Syndrome Acute Kidney Injury Cardio-Renal Syndrome Cardiovascular Diseases Decompensated Heart Failure Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Overload Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Ultrasound Therapy; Complications Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCG

Guadalajara, Jalisco, 44240, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vexus

Diagnostic Test

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.

Control Group

Other

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

Primary outcomes

  1. Kidney Function Recovery

    Time frame: 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 outcomes

  1. vascular decongestion during hospitalization

    Time frame: 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

Other outcomes

  1. Exploratory outcomes

    Time frame: 90 days

    days of hospitalization

  2. survival

    Time frame: 90 days

    dead for any cause

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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