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Cardiorenal SyndromeNCT05927285

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

A study testing Vexus in people with Cardiorenal Syndrome and Acute Kidney Injury, run by Hospital Civil de Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vexus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteMexico
Study dates
20 Mar 2022to 26 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cardiorenal Syndrome type 1

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • HCG

    Guadalajara, Jalisco, 44240

Other trials in Mexico

About this study

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.

Read the 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.

Being tested
Vexus, Control group
Medical subject headings
Cardio-Renal Syndrome, Acute Kidney Injury, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VexusDiagnostic 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 groupOther

    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

Study groups in NCT05927285
Study groupRoleWhat they receive
VeXUS groupExperimentalThe 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.
Receives: Diagnostic Test: Vexus
Control groupActive comparatorThe 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.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kidney Function Recovery

    Assess Kidney Function Recovery evaluated as serum Creatinine return to baseline value

    Measured: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days

Secondary outcomes (1)

  1. vascular decongestion during hospitalization

    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

    Measured: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start20 Mar 2022
  3. Primary completion20 Feb 2023
  4. Study completion26 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927285
Sponsor's protocol ID
HCG/CEI-0836/22
Status last verified
Jul 2023
First submitted
12 Jun 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: If researchers required we can share data

Publications

  • Hatamizadeh P, Fonarow GC, Budoff MJ, Darabian S, Kovesdy CP, Kalantar-Zadeh K. Cardiorenal syndrome: pathophysiology and potential targets for clinical management. Nat Rev Nephrol. 2013 Feb;9(2):99-111. doi: 10.1038/nrneph.2012.279. Epub 2012 Dec 18.

    PubMed 23247571

  • Chavez-Iniguez JS, Sanchez-Villaseca SJ, Garcia-Macias LA. [Cardiorenal syndrome: classification, pathophysiology, diagnosis and management. Literature review]. Arch Cardiol Mex. 2022 Apr 4;92(2):253-263. doi: 10.24875/ACM.20000183. Spanish.

    PubMed 34261129

  • Vandenberghe W, Gevaert S, Kellum JA, Bagshaw SM, Peperstraete H, Herck I, Decruyenaere J, Hoste EA. Acute Kidney Injury in Cardiorenal Syndrome Type 1 Patients: A Systematic Review and Meta-Analysis. Cardiorenal Med. 2016 Feb;6(2):116-28. doi: 10.1159/000442300. Epub 2015 Dec 19.

    PubMed 26989397

  • Chavez-Iniguez JS, Ibarra-Estrada M, Sanchez-Villaseca S, Romero-Gonzalez G, Font-Yanez JJ, De la Torre-Quiroga A, de Quevedo AA, Romero-Munoz A, Maggiani-Aguilera P, Chavez-Alonso G, Gomez-Fregoso J, Garcia-Garcia G. The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Pilot Randomized Trial. BMC Nephrol. 2022 Jan 3;23(1):3. doi: 10.1186/s12882-021-02637-y.

    PubMed 34979962

  • Husain-Syed F, Grone HJ, Assmus B, Bauer P, Gall H, Seeger W, Ghofrani A, Ronco C, Birk HW. Congestive nephropathy: a neglected entity? Proposal for diagnostic criteria and future perspectives. ESC Heart Fail. 2021 Feb;8(1):183-203. doi: 10.1002/ehf2.13118. Epub 2020 Nov 30.

    PubMed 33258308

  • Rocha BML, Menezes Falcao L. Acute decompensated heart failure (ADHF): A comprehensive contemporary review on preventing early readmissions and postdischarge death. Int J Cardiol. 2016 Nov 15;223:1035-1044. doi: 10.1016/j.ijcard.2016.07.259. Epub 2016 Aug 3.

    PubMed 27592046

  • Islas-Rodriguez JP, Miranda-Aquino T, Romero-Gonzalez G, Hernandez-Del Rio J, Camacho-Guerrero JR, Covarrubias-Villa S, Ivey-Miranda JB, Chavez-Iniguez JS. Effect on Kidney Function Recovery Guiding Decongestion with VExUS in Patients with Cardiorenal Syndrome 1: A Randomized Control Trial. Cardiorenal Med. 2024;14(1):1-11. doi: 10.1159/000535641. Epub 2023 Dec 7.

    PubMed 38061346

Questions about this trial

What is this clinical trial studying?

A study testing Vexus in people with Cardiorenal Syndrome and Acute Kidney Injury, run by Hospital Civil de Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kidney Function Recovery (time frame: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927285, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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