Acute Kidney InjuryECHO-AKINCT04095143
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
An observational study of Acute Kidney Injury and Fluid Overload, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Fluid Overload, Ultrasonography
- What is being tested?
- Portal vein flow, Intra-renal flow and Hepatic vein flow
- How many people
- 125 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 4 Sep 2018to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients with severe acute kidney injury
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
University of Alberta
Edmonton, Alberta
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H1X 2B9
Montreal Heart Institute
Montreal, Quebec
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
St. Michael's hospital
Toronto, Ontario, M5B 1W8
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Fluid Overload, Ultrasonography
- Being tested
- Portal vein flow, Intra-renal flow, Hepatic vein flow, Pulmonary B-lines, Dimensions of the inferior vena cava
- Keywords
- Point-Of-Care ultrasound, Doppler, Major adverse kidney events, Portal flow pulsatility, IVC ultrasound, Cardiac ultrasound, Right ventricular failure, Intensive care
- Medical subject headings
- Acute Kidney Injury, Edema, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (9)
Rate of in-hospital death
All cause mortality during hospital stay
Measured: 30 days
Number of participants with renal replacement therapy dependence at 30 days
Receipt of renal replacement therapy at 30 days from enrollment
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 30 days
Vasopressor-free days though day 30
Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin
Measured: 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)
Measured: 90 days
Rate of death at 90 days
All cause mortality at 90 days
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start4 Sep 2018
- Primary completion1 Jan 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre, University of Kentucky, University of Alberta, Montreal Heart Institute
- Responsible party
- Sponsor
- Investigators
- William Beaubien-Souligny, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095143
- Sponsor's protocol ID
- MP-02-2020-8578 (MP)
- Acronym
- ECHO-AKI
- Status last verified
- Nov 2022
- First submitted
- 17 Sep 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04095143
- Acronym / sponsor ID
- ECHO-AKI / MP-02-2020-8578 (MP)
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre, University of Kentucky, University of Alberta, Montreal Heart Institute
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New onset of stage ≥2 acute kidney injury | – | 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 functionEither: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients with severe acute kidney injury
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal vein flowDoppler assessment performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Intra-renal flowDoppler assessment performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Hepatic vein flowDoppler assessment performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Pulmonary B-linesUltrasound assessment of performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Dimensions of the inferior vena cavaUltrasound assessment of performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Left ventricular functionUltrasound assessment of performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
| Right ventricular functionUltrasound assessment of performed on day 0, 3 and 7. | Diagnostic test | New onset of stage ≥2 acute kidney injury |
Primary outcome
Number of participants with major adverse kidney events at 30 days
Time frame: 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)
9 secondary outcomes
Rate of in-hospital death
Time frame: 30 days
Number of participants with renal replacement therapy dependence at 30 days
Time frame: 30 days
Number of participants with sustained loss of kidney function at 30 days
Time frame: 30 days
Ventilation-free days through day 30
Time frame: 30 days
Intensive care unit (ICU)-free days through day 30
Time frame: 30 days
Vasopressor-free days though day 30
Time frame: 30 days
Number of participants with major adverse kidney events at 90 days
Time frame: 90 days
Rate of death at 90 days
Time frame: 90 days
Estimated glomerular filtration rate at 90 days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Beaubien-Souligny, MD principal investigator
CHUM
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Fluid Overload, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major adverse kidney events at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.