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

Primary Purpose

Acute Kidney Injury, Renal Insufficiency, Acute, Kidney; Disease, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
VExUS Score
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VExUS-Guided Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
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.

Full Information

First Posted
February 4, 2022
Last Updated
February 4, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05240833
Brief Title
VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Acronym
AKIVEX
Official Title
VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Insufficiency, Acute, Kidney; Disease, Acute, Critical Illness, Volume Overload, Fluid Overload

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VExUS-Guided Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
VExUS Score
Intervention Description
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.
Primary Outcome Measure Information:
Title
Renal replacement therapy
Description
Number of days free from renal replacement therapy during the first 28 days
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Day 28
Title
KDIGO category for AKI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARCIO M BONIATTI, PhD
Phone
+55 (51) 3359.8000
Email
mboniatti@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
MARCOS F RIHL, MD
Phone
+55 (51) 3359.8000
Email
marcosrihl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCIO M BONIATTI, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARCIO M BONIATTI, PhD
Phone
+55 (51) 3359.8000
Email
mboniatti@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
MARCOS F RIHL, MD
Phone
+55 (51) 3359.8000
Email
marcosrihl@gmail.com
First Name & Middle Initial & Last Name & Degree
MARCIO M BONIATTI, PhD
First Name & Middle Initial & Last Name & Degree
MARCOS F RIHL, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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