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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcomes | days of hospitalization | 90 days |
| survival | dead for any cause | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCG | Guadalajara | Jalisco | 44240 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23247571 | Result | 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. | |
| 34261129 | Result | 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. |
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If researchers required we can share data
2 weeks
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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.
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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.
| 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 |
|
| 26989397 | Result | 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. |
| 34979962 | Result | 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. |
| 33258308 | Result | 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. |
| 27592046 | Result | 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. |
| 38061346 | Derived | 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. |
| ID | Term |
|---|---|
| D059347 | Cardio-Renal Syndrome |
| D058186 | Acute Kidney Injury |
| D004487 | Edema |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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