Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

Centre hospitalier de l'Université de Montréal (CHUM)125 enrolled

Overview

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: * 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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Acute Kidney Injury

Interventions

Portal vein flowDIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Intra-renal flowDIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Hepatic vein flowDIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Pulmonary B-linesDIAGNOSTIC_TEST

Ultrasound assessment of performed on day 0, 3 and 7.

Dimensions of the inferior vena cavaDIAGNOSTIC_TEST

Ultrasound assessment of performed on day 0, 3 and 7.

Left ventricular functionDIAGNOSTIC_TEST

Ultrasound assessment of performed on day 0, 3 and 7.

Right ventricular functionDIAGNOSTIC_TEST

Ultrasound assessment of performed on day 0, 3 and 7.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of Kentucky

Lexington, Kentucky, United States

University of Alberta

Edmonton, Alberta, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

St. Michael's hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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