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

July 7, 2023 updated by: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44240
        • HCG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VeXUS group
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.
Diagnostic test: 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.
Active Comparator: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcomes
Time Frame: 90 days
days of hospitalization
90 days
survival
Time Frame: 90 days
dead for any cause
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 26, 2023

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCG/CEI-0836/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If researchers required we can share data

IPD Sharing Time Frame

2 weeks

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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