Portal vein flow
Diagnostic TestDoppler assessment performed on day 0, 3 and 7.
NCT Number: NCT04095143
Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury.
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Notify Me18 year and older
All sexes
Observational
University of Alberta, Edmonton, Alberta, Canada
Background: Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a direct mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications.
Objective: To determine whether ultrasound markers of organ congestions are associated with major adverse kidney events and other adverse clinical outcomes.
Study design: A cohort of critically ill patients with a new onset of severe acute kidney injury will undergo repeated ultrasound assessments to detect the presence of the following markers:
Clinical outcomes will be collected for up to 90 days after recruitment.
Perspective: An approach targeting the resolution of organ congestion might improve the prognosis in patients with severe acute kidney injury. Identifying clinically relevant markers of organ congestion is a precursor to the design of future interventional trials investigating personalized fluid balance management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Doppler assessment performed on day 0, 3 and 7.
Doppler assessment performed on day 0, 3 and 7.
Doppler assessment performed on day 0, 3 and 7.
Ultrasound assessment of performed on day 0, 3 and 7.
Ultrasound assessment of performed on day 0, 3 and 7.
Ultrasound assessment of performed on day 0, 3 and 7.
Ultrasound assessment of performed on day 0, 3 and 7.
Time frame: 30 days
Either death, receipt of renal replacement therapy or sustained loss of kidney function (new onset of estimated glomerular filtration rate (eGFR) < 60 or, if pre-existing eGFR < 60, 25% or greater decline in eGFR)
Time frame: 30 days
All cause mortality during hospital stay
Time frame: 30 days
Receipt of renal replacement therapy at 30 days from enrollment
Time frame: 30 days
New onset of estimated glomerular filtration rate (eGFR) < 60 or, if pre-existing eGFR < 60, 25% or greater decline in eGFR)
Time frame: 30 days
A ventilator-free day will be defined as the receipt of < 2 hours of either invasive or non-invasive ventilation within a 24-hour period.
Time frame: 30 days
An ICU-free day will be defined as admission to an ICU for < 2 hours within a 24 hours period.
Time frame: 30 days
Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin
Time frame: 90 days
Either death, receipt of renal replacement therapy or sustained loss of kidney function (estimated glomerular filtration rate (eGFR) < 60 or, if pre-existing eGFR < 60, 25% or greater decline in eGFR)
Time frame: 90 days
All cause mortality at 90 days
Time frame: 90 days
Calculated with the CKD-EPI equation (92) with serum creatinine from a sample drawn as close as possible to Day 90.
Time frame: 7 days
Intradialytic hypotension (MAP<65 mmHg) requiring one or more of the following interventions: interruption of fluid removal, introduction of norepinephrine or increase in its dose of more than 25%, administration of volume expansion or interruption of RRT within 8 hours after initiating net negative fluid balance.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Acronym: ECHO-AKI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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