Acute Kidney Injury, Cardiorenal Syndrome, Decompensated Heart Failure, Fluid Overload, Ultrasound Therapy; Complications
Conditions
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.
Interventions
DIAGNOSTIC_TESTVexus
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.
OTHERControl 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
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kidney Function Recovery | from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days | Assess Kidney Function Recovery evaluated as serum Creatinine return to baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vascular decongestion during hospitalization | from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcomes | 90 days | days of hospitalization |
| survival | 90 days | dead for any cause |
Countries
Mexico
Outcome results
None listed