Trials / Completed
CompletedNCT05927285
Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Hospital Civil de Guadalajara · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cardiorenal Syndrome
- Acute Kidney Injury
- Decompensated Heart Failure
- Fluid Overload
- Ultrasound Therapy; Complications
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-03-20
- Primary completion
- 2023-02-20
- Completion
- 2023-02-26
- First posted
- 2023-07-03
- Last updated
- 2023-07-10
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT05927285. Inclusion in this directory is not an endorsement.