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Completed

NCT Number: NCT04095143

Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portal vein flow

Diagnostic Test

Doppler assessment performed on day 0, 3 and 7.

Intra-renal flow

Diagnostic Test

Doppler assessment performed on day 0, 3 and 7.

Hepatic vein flow

Diagnostic Test

Doppler assessment performed on day 0, 3 and 7.

Pulmonary B-lines

Diagnostic Test

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

Dimensions of the inferior vena cava

Diagnostic Test

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

Left ventricular function

Diagnostic Test

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

Right ventricular function

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Montreal Heart Institute
  • Sunnybrook Health Sciences Centre
  • Unity Health Toronto
  • University of Alberta
  • University of Kentucky

Registry information

Acronym: ECHO-AKI

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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