Clinical trial NCT06411080: UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury
Official title: UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: point-of-care ultrasound
VExUS
Lung ultrasound
Fluid therapy
acute kidney injury
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI). While it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery, there are potential harms involved in indiscriminate administration of intravenous fluids. Although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered, it has been suggested that using Point-Of-Care ultrasound (POCUS) may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision\[1\]. However, it has not been shown that providing this information in the context of AKI result in a change in management or a prevention of complications.

This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI. In the intervention group, a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team. This assessment will be repeated 48-72 hours later. The primary aim of the study will be to establish the feasibility of this intervention. Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration, diuretic use, evolution of kidney function, and intensification of care.


Eligibility criteria: Inclusion Criteria:

1. Adults ≥ 18 year-old
2. Admitted to the hospital
3. Acute kidney injury defined by the KDIGO criteria\[48\]
4. Fluid expansion is considered by attending nephrologist or already ongoing

Exclusion Criteria:

1. Admitted to the intensive care unit
2. Known stage 5 chronic kidney disease according to the KDIGO classification receiving renal replacement therapy or not.
3. Renal replacement therapy for AKI has been initiated or is planned within 24 hours

Primary outcomes:
measure: Protocol adherence
timeFrame: 30 days
Secondary outcomes:
measure: Cumulative intravenous fluid
timeFrame: 5 days
measure: Diuretic use
timeFrame: 5 days
measure: Kinetic estimated glomerular filtration rate (KeGFR)
timeFrame: 5 days
measure: Progression to a higher stage of AKI
timeFrame: 5 days
measure: Death or escalation of care
timeFrame: 10 days
Other outcomes:
measure: Kidney and liver stiffness
timeFrame: 5 days
measure: Fluid responsiveness
timeFrame: 5 days
measure: The perceived usefulness of the ultrasound report
timeFrame: 5 days
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre Hospitalier d'Université de Montréal
name: William Beaubien-Souligny, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: