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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Acute Kidney Injury; Fluid Overload; Renal Insufficiency, Acute; Volume Overload; Kidney; Disease, Acute
• Intervention / Treatment: Diagnostic test: VExUS Score

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.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARCIO M BONIATTI, PhD; Phone Number: +55 (51) 3359.8000; Email: mboniatti@hcpa.edu.br
• Study Contact Backup: Name: MARCOS F RIHL, MD; Phone Number: +55 (51) 3359.8000; Email: marcosrihl@gmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: MARCIO M BONIATTI, PhD; Phone Number: +55 (51) 3359.8000; Email: mboniatti@hcpa.edu.br
      • Contact: MARCOS F RIHL, MD; Phone Number: +55 (51) 3359.8000; Email: marcosrihl@gmail.com
      • Principal Investigator: Marcio M Boniatti, PhD
      • Sub-Investigator: MARCOS F RIHL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal replacement therapy	Number of days free from renal replacement therapy during the first 28 days	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		Day 28
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.	48 hours

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: MARCIO M BONIATTI, PhD, Hospital De Clinicas De Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Wounds and Injuries; Renal Insufficiency; Critical Illness; Acute Kidney Injury; Acute Disease
• Other Study ID Numbers: 2021-0487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No