An observational study in Acute Kidney Injury, Fluid Overload and Ultrasonography, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
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.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's enrollment of 125 is below the median of 156 across 795 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill adult patients with severe acute kidney injury
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Either: 1. A ≥ 2-fold increase in serum creatinine OR 2. A serum creatinine ≥ 354 μmol/L with evidence of a minimum increase of 27 μmol/L OR 3. Urine output \< 6.0 mL/kg over the preceding 12 hours OR 4. Initiation of RRT for severe acute kidney injury less than 72 hours before recruitment
Diagnostic Test: Portal vein flow · Diagnostic Test: Intra-renal flow · Diagnostic Test: Hepatic vein flow · Diagnostic Test: Pulmonary B-lines · Diagnostic Test: Dimensions of the inferior vena cava · Diagnostic Test: Left ventricular function · Diagnostic Test: Right ventricular function
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.
Number of participants with major adverse kidney events at 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
Rate of in-hospital death
All cause mortality during hospital stay
Time frame: 30 days
Number of participants with renal replacement therapy dependence at 30 days
Receipt of renal replacement therapy at 30 days from enrollment
Time frame: 30 days
Number of participants with sustained loss of kidney function at 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
Ventilation-free days through day 30
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
Intensive care unit (ICU)-free days through day 30
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-free days though day 30
Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin
Time frame: 30 days
Number of participants with major adverse kidney events at 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
Rate of death at 90 days
All cause mortality at 90 days
Time frame: 90 days
Estimated glomerular filtration rate at 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: 90 days
Hemodynamic instability during renal replacement therapy
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.
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in Jan 2022, 39 months.
Of 337 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 39 months is above that.
Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 13 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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