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Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury (ECHO-AKI)

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ClinicalTrials.gov Identifier: NCT04095143
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : August 9, 2021
Sponsor:
Collaborators:
Unity Health Toronto
Sunnybrook Health Sciences Centre
University of Kentucky
University of Alberta
Montreal Heart Institute
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Fluid Overload Ultrasonography 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

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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
Diagnostic Test: Portal vein flow
Doppler assessment performed on day 0, 3 and 7.

Diagnostic Test: Intra-renal flow
Doppler assessment performed on day 0, 3 and 7.

Diagnostic Test: Hepatic vein flow
Doppler assessment performed on day 0, 3 and 7.

Diagnostic Test: Pulmonary B-lines
Ultrasound assessment of performed on day 0, 3 and 7.

Diagnostic Test: Dimensions of the inferior vena cava
Ultrasound assessment of performed on day 0, 3 and 7.

Diagnostic Test: Left ventricular function
Ultrasound assessment of performed on day 0, 3 and 7.

Diagnostic Test: Right ventricular function
Ultrasound assessment of performed on day 0, 3 and 7.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Rate of in-hospital death [ Time Frame: 30 days ]
    All cause mortality during hospital stay

  2. Number of participants with renal replacement therapy dependence at 30 days [ Time Frame: 30 days ]
    Receipt of renal replacement therapy at 30 days from enrollment

  3. Number of participants with sustained loss of kidney function at 30 days [ Time Frame: 30 days ]
    New onset of estimated glomerular filtration rate (eGFR) < 60 or, if pre-existing eGFR < 60, 25% or greater decline in eGFR)

  4. Ventilation-free days through day 30 [ Time Frame: 30 days ]
    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.

  5. Intensive care unit (ICU)-free days through day 30 [ Time Frame: 30 days ]
    An ICU-free day will be defined as admission to an ICU for < 2 hours within a 24 hours period.

  6. Vasopressor-free days though day 30 [ Time Frame: 30 days ]
    Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin

  7. Number of participants with major adverse kidney events at 90 days [ Time Frame: 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)

  8. Rate of death at 90 days [ Time Frame: 90 days ]
    All cause mortality at 90 days

  9. Estimated glomerular filtration rate at 90 days [ Time Frame: 90 days ]
    Calculated with the CKD-EPI equation (92) with serum creatinine from a sample drawn as close as possible to Day 90.


Other Outcome Measures:
  1. Hemodynamic instability during renal replacement therapy [ Time Frame: 7 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill adult patients with severe acute kidney injury
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095143


Contacts
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Contact: William Beaubien-Souligny, MD 514-890-8000 ext 36369 william.beaubien@gmail.com

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Javier Neyra Lozano, MD         
Canada, Alberta
University of Alberta Active, not recruiting
Edmonton, Alberta, Canada
Canada, Ontario
Sunnybrook Health Science Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
St. Michael's hospital Active, not recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute Active, not recruiting
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal Active, not recruiting
Montréal, Quebec, Canada, H1X 2B9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Unity Health Toronto
Sunnybrook Health Sciences Centre
University of Kentucky
University of Alberta
Montreal Heart Institute
Investigators
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Principal Investigator: William Beaubien-Souligny, MD CHUM
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04095143    
Other Study ID Numbers: MP-02-2020-8578 (MP)
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Point-Of-Care ultrasound
Doppler
Major adverse kidney events
Portal flow pulsatility
IVC ultrasound
Cardiac ultrasound
Right ventricular failure
Intensive care
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases