UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury

NCT ID: NCT06411080

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2025-10-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound evaluation of fluid tolerance

Intervention Type: 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.

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Beaubien-Souligny, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier d'Université de Montréal

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2025-12250

Identifier Type: -

Identifier Source: org_study_id