Clinical trial NCT04095143: Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Official title: Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Fluid Overload
Ultrasonography
Keywords: Point-Of-Care ultrasound
Doppler
Major adverse kidney events
Portal flow pulsatility
IVC ultrasound
Cardiac ultrasound
Right ventricular failure
Intensive care
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
name: University of Kentucky
name: University of Alberta
name: Montreal Heart Institute
First posted: 2019-09-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients with severe acute kidney injury

Brief summary: 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.

Detailed description: 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:

* Portal flow pulsatility on pulse-wave Doppler
* Discontinuous intra-renal venous flow on pulse-wave Doppler
* Abnormal hepatic vein waveform on pulse wave Doppler
* Presence of pulmonary B-line artifacts on 2D lung ultrasound
* Presence of dilated and non-collapsible inferior vena cava on 2D ultrasound
* Presence of systolic right ventricular dysfunction
* Presence of systolic left ventricular dysfunction

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admitted to the ICU
* Women with serum creatinine ≥ 100 µmol/L and men with serum creatinine ≥ 130 µmol/L
* 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 achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization OR Urine output \< 6.0 mL/kg over the preceding 12 hours OR initiation of renal replacement therapy (RRT) for severe AKI initiated less than 72 hours before recruitment.

Exclusion Criteria:

* Lack of commitment to provide RRT as part of limitation of ongoing life support. (Operational definition: Critical care team has deemed the patient not to be eligible for escalation of life support, including the initiation of RRT, or substitute decision makers have declined offer of same.)
* Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 20 mL/min/1.73 m2 in a patient who is not on chronic RRT. (Operational definition: The coordinator will review all documented serum creatinine values within 365 days prior to the date of admission for the current hospitalization. The value closest to the admission date will be considered as the "baseline" and will be used to calculate the corresponding estimated glomerular filtration rate using an online calculator. A value of \< 20 mL/min/1.73 m2 derived from the CKD-EPI equation will be grounds for exclusion.

Primary outcomes:
measure: Number of participants with major adverse kidney events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Rate of in-hospital death
timeFrame: 30 days
measure: Number of participants with renal replacement therapy dependence at 30 days
timeFrame: 30 days
measure: Number of participants with sustained loss of kidney function at 30 days
timeFrame: 30 days
measure: Ventilation-free days through day 30
timeFrame: 30 days
measure: Intensive care unit (ICU)-free days through day 30
timeFrame: 30 days
measure: Vasopressor-free days though day 30
timeFrame: 30 days
measure: Number of participants with major adverse kidney events at 90 days
timeFrame: 90 days
measure: Rate of death at 90 days
timeFrame: 90 days
measure: Estimated glomerular filtration rate at 90 days
timeFrame: 90 days
Other outcomes:
measure: Hemodynamic instability during renal replacement therapy
timeFrame: 7 days
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: CHUM
name: William Beaubien-Souligny, MD
role: PRINCIPAL_INVESTIGATOR
References: