Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
NCT ID: NCT04095143
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2018-09-04
2022-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New onset of stage ≥2 acute kidney injury
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Sunnybrook Health Sciences Centre
OTHER
University of Kentucky
OTHER
University of Alberta
OTHER
Montreal Heart Institute
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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William Beaubien-Souligny, MD
Role: PRINCIPAL_INVESTIGATOR
CHUM
Locations
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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
Countries
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Other Identifiers
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MP-02-2020-8578 (MP)
Identifier Type: -
Identifier Source: org_study_id
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