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

Sponsor

Hospital Civil de Guadalajara (Other)

Overall Status

Completed

CT.gov ID

NCT05927285

Collaborator

(none)

140

Enrollment

Location

Arms

11.3

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiorenal Syndrome Acute Kidney Injury Decompensated Heart Failure Fluid Overload Ultrasound Therapy; Complications	Diagnostic Test: Vexus Other: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model 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. 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.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. 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.

Masking:

Single (Participant)

Masking Description:

Allocation was performed by the cardiology staff on a concealed opaque envelope until the beginning of the study. A double-blind, double dummy design was used.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2022

Actual Primary Completion Date :

Feb 20, 2023

Actual Study Completion Date :

Feb 26, 2023

Arms and Interventions

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

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

Active Comparator: Control group

Other: Control group

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Exploratory outcomes [90 days]
days of hospitalization
survival [90 days]
dead for any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HCG	Guadalajara	Jalisco	Mexico	44240

Sponsors and Collaborators

Hospital Civil de Guadalajara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Samuel Chavez Iñiguez, Dr., Hospital Civil de Guadalajara

ClinicalTrials.gov Identifier:

NCT05927285

Other Study ID Numbers:

HCG/CEI-0836/22

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Cardio-Renal Syndrome

Syndrome

Study Results

No Results Posted as of Jul 10, 2023