Acute Kidney InjuryUSE-the-FORCENCT06411080
UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury
A study testing Ultrasound evaluation of fluid tolerance in people with Acute Kidney Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Ultrasound evaluation of fluid tolerance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3H8
About this study
Official title: 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Ultrasound evaluation of fluid tolerance
- Keywords
- point-of-care ultrasound, VExUS, Lung ultrasound, Fluid therapy, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluation of fluid toleranceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasound evaluation of fluid tolerance |
| Usual care | No intervention | Usual care without information from Point-Of-Care ultrasound assessment of fluid tolerance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence
: Ultrasound assessments were performed as planned and the reports were generated and transmitted to the attending care team in the prespecified periods.
Measured: 30 days
Secondary outcomes (5)
Cumulative intravenous fluid
Amount of fluid in mL received
Measured: 5 days
Diuretic use
defined as the use of loop diuretics
Measured: 5 days
Kinetic estimated glomerular filtration rate (KeGFR)
Kinetic estimated glomerular filtration rate (KeGFR) will be derived from serial measurements in serum creatinine
Measured: 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.
Measured: 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)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start17 Oct 2024
- Primary completion29 Sep 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Beaubien-Souligny, MD PhD, Principal investigator, Centre Hospitalier d'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411080
- Sponsor's protocol ID
- 2025-12250
- Other IDs
- 2025
- Acronym
- USE-the-FORCE
- Status last verified
- Sep 2025
- First submitted
- 8 May 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gouin M, Huard K, Shen A, Cote JM, Denault A, Beaubien-Souligny W. A Pilot Randomized Controlled Trial of Ultrasound Evaluation of Fluid Tolerance for Acute Kidney Injury: USE-the-FORCE-for-AKI Trial. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1126-1134. doi: 10.2215/CJN.0000001059. Epub 2026 Apr 21.
PubMed 42012891
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06411080
- Acronym / sponsor ID
- USE-the-FORCE / 2025-12250
- Conditions
- Acute Kidney Injury
- Keywords
- point-of-care ultrasound, VExUS, Lung ultrasound, Fluid therapy, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Management with ultrasound information | Experimental | Diagnostic Test: Ultrasound evaluation of fluid toleranceAn 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. |
| Usual care | No intervention | –Usual care without information from Point-Of-Care ultrasound assessment of fluid tolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound evaluation of fluid toleranceLung 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. | Diagnostic test | Management with ultrasound information |
Primary outcome
Protocol adherence
Time frame: 30 days
: Ultrasound assessments were performed as planned and the reports were generated and transmitted to the attending care team in the prespecified periods.
5 secondary outcomes
Cumulative intravenous fluid
Time frame: 5 days
Diuretic use
Time frame: 5 days
Kinetic estimated glomerular filtration rate (KeGFR)
Time frame: 5 days
Progression to a higher stage of AKI
Time frame: 5 days
Death or escalation of care
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 42012891Gouin M, Huard K, Shen A, Cote JM, Denault A, Beaubien-Souligny W. A Pilot Randomized Controlled Trial of Ultrasound Evaluation of Fluid Tolerance for Acute Kidney Injury: USE-the-FORCE-for-AKI Trial. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1126-1134. doi: 10.2215/CJN.0000001059. Epub 2026 Apr 21.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Beaubien-Souligny, MD PhD principal investigator
Centre Hospitalier d'Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound evaluation of fluid tolerance in people with Acute Kidney Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol adherence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06411080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.