Clinical trial NCT05927285: Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1
Official title: Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorenal Syndrome
Acute Kidney Injury
Decompensated Heart Failure
Fluid Overload
Ultrasound Therapy; Complications
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kidney Function Recovery
timeFrame: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days
Secondary outcomes:
measure: vascular decongestion during hospitalization
timeFrame: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days
Other outcomes:
measure: Exploratory outcomes
timeFrame: 90 days
measure: survival
timeFrame: 90 days
Locations:
city: Guadalajara
country: Mexico
facility: HCG
state: Jalisco
Study officials:
References:
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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/ehf2.13118. Epub 2020 Nov 30.
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