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

NCT ID: NCT05240833

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2022-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VExUS Score

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARCIO M BONIATTI, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

MARCIO M BONIATTI, PhD

Role: CONTACT

mboniatti@hcpa.edu.br

+55 (51) 3359.8000

MARCOS F RIHL, MD

Role: CONTACT

marcosrihl@gmail.com

+55 (51) 3359.8000

Facility Contacts

MARCIO M BONIATTI, PhD

Role: primary

mboniatti@hcpa.edu.br

+55 (51) 3359.8000

MARCOS F RIHL, MD

Role: backup

marcosrihl@gmail.com

+55 (51) 3359.8000

Other Identifiers

2021-0487

Identifier Type: -

Identifier Source: org_study_id