UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury

NCT06411080 | Completed DMC

• 1 other identifier: 2025-12250
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

point-of-care ultrasound; VExUS; Lung ultrasound; Fluid therapy; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Protocol adherence

  : Ultrasound assessments were performed as planned and the reports were generated and transmitted to the attending care team in the prespecified periods.

  30 days

Secondary Outcomes (5)

• Cumulative intravenous fluid

  5 days

• Diuretic use

  5 days

• Kinetic estimated glomerular filtration rate (KeGFR)

  5 days

• Progression to a higher stage of AKI

  5 days

• Death or escalation of care

  10 days

Other Outcomes (2)

• Kidney and liver stiffness

  5 days

• The perceived usefulness of the ultrasound report

  5 days

Study Arms (2)

Management with ultrasound information

EXPERIMENTAL

An ultrasound report will be provided to the attending care team. The report will contain information related to abdominal and thoracic ultrasound exams with expert interpretation regarding anticipated risks of fluid administration.

Diagnostic Test: Ultrasound evaluation of fluid tolerance

Usual care

NO INTERVENTION

Usual care without information from Point-Of-Care ultrasound assessment of fluid tolerance.

Interventions

Ultrasound evaluation of fluid tolerance DIAGNOSTIC_TEST

Lung ultrasound for the assessment of B-line artifact and pleural effusion combined with abdominal ultrasound for VExUS assessment. The imaging study will be reviewed by an expert for will generate a report with interpretation regarding the risk of fluid administration. The assessment will be performed at baseline and after 48 hours after randomization.

Management with ultrasound information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3H8, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• William Beaubien-Souligny, MD PhD

  Centre Hospitalier d'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: October 17, 2024
• Primary Completion: September 29, 2025
• Study Completion: October 22, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)