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

Not Applicable

• Conditions: Critical Illness; Renal Insufficiency, Acute; Kidney; Disease, Acute; Acute Kidney Injury; Volume Overload; Fluid Overload
• Interventions: Diagnostic Test: VExUS Score

• Registration Number: NCT05240833
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2022-01-07
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VExUS-Guided Arm	VExUS Score	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.

Primary Outcome Measures

Name	Time	Method
Renal replacement therapy	Day 28	Number of days free from renal replacement therapy during the first 28 days

Secondary Outcome Measures

Name	Time	Method
Mortality	Day 28
KDIGO category for AKI	48 hours	Variation in Kidney Disease: Improving Global Outcomes (KDIGO) criteria for AKI after 48 hours. Reducing the KDIGO category is a better outcome.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil