Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

NCT ID: NCT04095143

Last Updated: 2022-11-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-04

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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

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Acute Kidney Injury Fluid Overload Ultrasonography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Intra-renal flow

Intervention Type DIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Hepatic vein flow

Intervention Type DIAGNOSTIC_TEST

Doppler assessment performed on day 0, 3 and 7.

Pulmonary B-lines

Intervention Type DIAGNOSTIC_TEST

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

Dimensions of the inferior vena cava

Intervention Type DIAGNOSTIC_TEST

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

Left ventricular function

Intervention Type DIAGNOSTIC_TEST

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

Right ventricular function

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Intra-renal flow

Doppler assessment performed on day 0, 3 and 7.

Intervention Type DIAGNOSTIC_TEST

Hepatic vein flow

Doppler assessment performed on day 0, 3 and 7.

Intervention Type DIAGNOSTIC_TEST

Pulmonary B-lines

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

Intervention Type DIAGNOSTIC_TEST

Dimensions of the inferior vena cava

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

Intervention Type DIAGNOSTIC_TEST

Left ventricular function

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

Intervention Type DIAGNOSTIC_TEST

Right ventricular function

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

St. Michael's hospital

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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MP-02-2020-8578 (MP)

Identifier Type: -

Identifier Source: org_study_id

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