NCT05927285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 12, 2023

Last Update Submit

July 7, 2023

Conditions

Cardiorenal SyndromeAcute Kidney InjuryDecompensated Heart FailureFluid OverloadUltrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

  • Kidney Function Recovery

    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 Outcomes (1)

  • vascular decongestion during hospitalization

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

Other Outcomes (2)

  • Exploratory outcomes

    90 days

  • survival

    90 days

Study Arms (2)

VeXUS group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

VeXUS group
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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiorenal Syndrome type 1

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCG

Guadalajara, Jalisco, 44240, Mexico

Location

Related Publications (7)

  • 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.

    PMID: 23247571RESULT

  • 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.

    PMID: 34261129RESULT

  • 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.

    PMID: 26989397RESULT

  • 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.

    PMID: 34979962RESULT

  • 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.

    PMID: 33258308RESULT

  • 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.

    PMID: 27592046RESULT

  • 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.

    PMID: 38061346DERIVED

MeSH Terms

Conditions

Cardio-Renal SyndromeAcute Kidney InjuryEdema

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 3, 2023

Study Start

March 20, 2022

Primary Completion

February 20, 2023

Study Completion

February 26, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

If researchers required we can share data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2 weeks

Locations

ME(1)