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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05240833
Other study ID # 2021-0487
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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