UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury (USE-the-FORCE)

UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: Ultrasound evaluation of fluid tolerance

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3H8
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Management with ultrasound information; 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; 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.
No Intervention: Usual care; Usual care without information from Point-Of-Care ultrasound assessment of fluid tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative intravenous fluid	Amount of fluid in mL received	5 days
Diuretic use	defined as the use of loop diuretics	5 days
Kinetic estimated glomerular filtration rate (KeGFR)	Kinetic estimated glomerular filtration rate (KeGFR) will be derived from serial measurements in serum creatinine	5 days
Progression to a higher stage of AKI	Progression to a higher stage of AKI will be defined as any increase in the KDIGO staging criteria of increase in creatinine: Operational definition: Increase in at least one level compared to baseline AKI staging during the first 5 days: Stage 1: Increase in serum creatinine by ≥26.5 µmol/L within 48 hours or increase to 1.5-1.9 times baseline within the last 7 days. Stage 2: Increase in serum creatinine to 2.0-2.9 times baseline. Stage 3: Increase in serum creatinine to ≥3.0 times baseline or increase to ≥354 µmol/L, Stage 3D: Initiation of renal replacement therapy.	5 days
Death or escalation of care	composite endpoint defined as the occurrence of at least one of the following events occurring within 10 days after randomization: death from any cause, intervention of the rapid response team, admission to the intensive care unit, initiation of non-invasive positive pressure ventilation, initiation of renal replacement therapy. (Binary - Yes/no)	10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney and liver stiffness	median values of shear-wave propagation speed in m/sec obtained by shear-wave elastography assessment of the respective organ parenchyma.	5 days
The perceived usefulness of the ultrasound report	be reported on a sliding scale from 0 to 5. A score of 0 will mean that the information is considered useless while a score of 5 will mean that the information provided had a critical impact of clinical management. (Continuous - points)	5 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: William Beaubien-Souligny, MD PhD, Centre Hospitalier d'Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Actual): September 29, 2025
• Study Completion (Actual): October 22, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Lung ultrasound; acute kidney injury; Fluid therapy; point-of-care ultrasound; VExUS
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2025-12250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No