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

Critical Illness Clinical Trial

— AKIVEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240833
• Other study ID #: 2021-0487
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: MARCIO M BONIATTI, PhD
• Phone: +55 (51) 3359.8000
• Email: mboniatti[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Kidney Injury
• Critical Illness
• Fluid Overload
• Kidney; Disease, Acute
• Renal Insufficiency
• Renal Insufficiency, Acute
• Volume Overload
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal replacement therapy	Number of days free from renal replacement therapy during the first 28 days	Day 28
Secondary	Mortality		Day 28
Secondary	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