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Status unknownNCT05240833AKIVEXUpdated Feb 15, 2022

VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit

An interventional study of VExUS Score in Acute Kidney Injury, Renal Insufficiency, Acute and Kidney; Disease, Acute, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A quasi experimental study that aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

Read the detailed description

Fluid overload is associated with organ dysfunction, such as Acute Kidney Injury (AKI), and increased mortality. It remains unclear if fluid overload is merely an epiphenomenon in critically ill patients or if organ congestion is a mediator of complications. Considering AKI related to fluid overload, diuretic therapy would reduce venous congestion and improve renal blood flow. The Venous Excess Ultrasound score (VExUS) identifies clinically significant venous congestion and indicates a high risk of post-operative AKI. This quasi-experimental study aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

02

Conditions studied

  • Acute Kidney Injury
  • Renal Insufficiency, Acute
  • Kidney; Disease, Acute
  • Critical Illness
  • Volume Overload
  • Fluid Overload
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 55 is below the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-elective ICU admission
  • Severe acute kidney injury (AKI) defined either: A ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization OR Urine output \< 6.0 mL/kg over the preceding 12 hours

Exclusion criteria

Exclusion Criteria:

  • Life-threatening indication of RRT (defined as intractable hyperkalaemia, acidosis, uraemic symptoms) at Day 0
  • RRT before recruitment
  • Use of Extracorporeal membrane oxygenation (ECMO)
  • Hepatic cirrhosis or other condition with portal hypertension
  • Lack of commitment to provide RRT as part of limitation of ongoing life support
  • Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or chronic RRT
  • Refusal to sign the informed consent form
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    VExUS-Guided Arm

    VExUS results will be available for the treating physician. Patients will be treated according to current clinical practice. The use of diuretic and diuretic dosage will depend on treating physician's criteria.

    Diagnostic Test: VExUS Score

Interventions

  • Diagnostic testVExUS Score

    The VExUS-Guided Arm care team will be informed of the Day 0 VExUS immediately after the ultrasound is performed and given a suggested target for the following 48 hours as follows: * VExUS 0: There is no evidence of venous congestion. * VExUS 1: There is evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis. * VExUS 2-3: There is evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis. * If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.

06

What researchers measure

Primary outcomes

  1. Renal replacement therapy

    Number of days free from renal replacement therapy during the first 28 days

    Time frame: Day 28

Secondary outcomes

  1. Mortality

    Time frame: Day 28

  2. KDIGO category for AKI

    Variation in Kidney Disease: Improving Global Outcomes (KDIGO) criteria for AKI after 48 hours. Reducing the KDIGO category is a better outcome.

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    • MARCIO M BONIATTI, PhD · Contact · mboniatti@hcpa.edu.br · +55 (51) 3359.8000
    • MARCOS F RIHL, MD · Contact · marcosrihl@gmail.com · +55 (51) 3359.8000
    • MARCIO M BONIATTI, PhD · Principal investigator
    • MARCOS F RIHL, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05240833
Responsible party
Sponsor
First posted
Feb 15, 2022
Start date
Jan 7, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Feb 15, 2022

Study contacts

MARCIO M BONIATTI, PhD
Contact
mboniatti@hcpa.edu.br
+55 (51) 3359.8000
MARCOS F RIHL, MD
Contact
marcosrihl@gmail.com
+55 (51) 3359.8000
MARCIO M BONIATTI, PhD
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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