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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| University of Kentucky | OTHER |
| University of Alberta |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New onset of stage ≥2 acute kidney injury | Either:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portal vein flow | Diagnostic Test | Doppler assessment performed on day 0, 3 and 7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of in-hospital death | All cause mortality during hospital stay | 30 days |
| Number of participants with renal replacement therapy dependence at 30 days | Receipt of renal replacement therapy at 30 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Critically ill adult patients with severe acute kidney injury
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| Name | Affiliation | Role |
|---|---|---|
| William Beaubien-Souligny, MD | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States | ||
| University of Alberta |
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| OTHER |
| Montreal Heart Institute | OTHER |
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| 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. |
|
| 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) | 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. | 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. | 30 days |
| Vasopressor-free days though day 30 | Vasopressor will include norepinephrine, epinephrine, vasopressin and phenylephrin | 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) | 90 days |
| Rate of death at 90 days | All cause mortality at 90 days | 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. | 90 days |
| Edmonton |
| Alberta |
| Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H1X 2B9 | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D004487 | Edema |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016277 | Ventricular Function, Left |
| D016278 | Ventricular Function, Right |
| ID | Term |
|---|---|
| D016276 | Ventricular Function |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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