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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927285
• Other study ID #: HCG/CEI-0836/22
• Status: Completed
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: February 26, 2023

Study information

• Verified date: July 2023
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The venous evaluation by ultrasound (VExUS) may optimize its management when evaluating for improvement in kidney function and other metrics related to decongestion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 26, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Decompensated Heart Failure
• Fluid Overload
• Syndrome
• Ultrasound Therapy; Complications

Intervention

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.

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

Locations

Country	Name	City	State
Mexico	HCG	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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 Vasc — View Citation

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. — View Citation

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. — View Citation

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/ehf2.1311 — View Citation

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 — View Citation

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: 10.1159/00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcomes	days of hospitalization	90 days
Other	survival	dead for any cause	90 days
Primary	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	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