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

NCT05240833 | Unknown

• 1 other identifier: 2021-0487
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Renal replacement therapy

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

  Day 28

Secondary Outcomes (2)

• Mortality

  Day 28

• KDIGO category for AKI

  48 hours

Study Arms (1)

VExUS-Guided Arm

EXPERIMENTAL

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

VExUS Score DIAGNOSTIC_TEST

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.

VExUS-Guided Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Disease; Critical Illness; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Signs and Symptoms

Study Officials

• MARCIO M BONIATTI, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCIO M BONIATTI, PhD

CONTACT

+55 (51) 3359.8000; mboniatti@hcpa.edu.br

MARCOS F RIHL, MD

CONTACT

+55 (51) 3359.8000; marcosrihl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: January 7, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)