UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— USE-the-FORCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411080
• Other study ID #: 2025-12250
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: William Beaubien-Souligny, MD PhD
• Phone: 5148908000
• Email: william.beaubien-souligny[@]umontral.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Fluid responsiveness	increase of 7 msec or more in the corrected carotid flow time following a passive leg raising manoeuvre.[47] (Binary - Yes/no)	5 days
Other	The perceived usefulness of the ultrasound report	be reported on a sliding scale from 0 to 10. A score of 0 will mean that the information is considered useless while a score of 10 will mean that the information provided had a critical impact of clinical management. (Continuous - points)	5 days
Primary	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	Cumulative intravenous fluid	Amount of fluid in mL received	5 days
Secondary	Diuretic use	defined as the use of loop diuretics	5 days
Secondary	Kinetic estimated glomerular filtration rate (KeGFR)	Kinetic estimated glomerular filtration rate (KeGFR) will be derived from serial measurements in serum creatinine	5 days
Secondary	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
Secondary	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