Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— ECHO-AKI  

Official title:

Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095143
• Other study ID #: MP-02-2020-8578 (MP)
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fluid Overload
• Ultrasonography
• Wounds and Injuries

Intervention

Diagnostic Test:
• Portal vein flow
Doppler assessment performed on day 0, 3 and 7.
• Intra-renal flow
Doppler assessment performed on day 0, 3 and 7.
• Hepatic vein flow
Doppler assessment performed on day 0, 3 and 7.
• Pulmonary B-lines
Ultrasound assessment of performed on day 0, 3 and 7.
• Dimensions of the inferior vena cava
Ultrasound assessment of performed on day 0, 3 and 7.
• Left ventricular function
Ultrasound assessment of performed on day 0, 3 and 7.
• Right ventricular function
Ultrasound assessment of performed on day 0, 3 and 7.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	St. Michael's hospital	Toronto	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
United States	University of Kentucky	Lexington	Kentucky

Sponsors (6)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Montreal Heart Institute, Sunnybrook Health Sciences Centre, Unity Health Toronto, University of Alberta, University of Kentucky

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	7 days
Primary	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)	30 days
Secondary	Rate of in-hospital death	All cause mortality during hospital stay	30 days
Secondary	Number of participants with renal replacement therapy dependence at 30 days	Receipt of renal replacement therapy at 30 days from enrollment	30 days
Secondary	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)	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	Vasopressor-free days though day 30	Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin	30 days
Secondary	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)	90 days
Secondary	Rate of death at 90 days	All cause mortality at 90 days	90 days
Secondary	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.	90 days