Ultrasound Evaluation for Acute Kidney Injury

(USE-the-FORCE Trial)

No longer recruiting at 1 trial location

Overseen By William Beaubien-Souligny, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: ICU admission, Stage 5 CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ultrasound (an imaging technique using sound waves) can help doctors manage fluid treatment for patients with acute kidney injury (AKI) more effectively. The goal is to determine if ultrasounds can predict which patients might experience complications from fluid treatments, aiding doctors in making informed decisions. One group will receive usual care, while the other will undergo an ultrasound assessment to guide treatment (ultrasound evaluation of fluid tolerance). Patients admitted to the hospital with AKI who are not in intensive care may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future AKI treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound evaluation is safe for patients with acute kidney injury?

Research has shown that using Point-Of-Care ultrasound (POCUS) to check fluid levels in patients with acute kidney injury (AKI) is generally safe. POCUS allows doctors to see inside the body using sound waves. Studies indicate it can help doctors make better decisions about fluid treatment, reducing the risk of complications like fluid overload.

No specific information exists about side effects or risks from the ultrasound itself. Ultrasound is a common and non-invasive procedure, meaning it doesn't involve surgery or entering the body. It is well-tolerated and not known to cause harm.

Overall, using ultrasound in this way appears safe and may help manage fluid levels more accurately in patients with AKI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound evaluations for acute kidney injury because it introduces a new way to assess fluid tolerance quickly and non-invasively. Unlike standard methods that rely heavily on lab tests and clinical judgment, this approach provides real-time, expert-interpreted ultrasound data on the abdomen and thorax. This detailed imaging helps doctors make more informed decisions about fluid administration, potentially reducing the risks associated with misjudging a patient's fluid needs.

What evidence suggests that using ultrasound evaluation is effective for managing acute kidney injury?

This trial will compare usual care with management that uses information from Point-Of-Care ultrasound (POCUS) for patients with acute kidney injury (AKI). Research has shown that POCUS might help doctors identify patients with sudden kidney problems who are at high risk of complications from fluid treatment. This could assist doctors in making better decisions about fluid administration. POCUS provides detailed information that can help avoid issues like fluid overload by assessing a patient's fluid tolerance. However, it is not yet proven that using this information changes how doctors treat AKI or prevents these problems. Early findings suggest that POCUS might improve patient outcomes, but more research is needed to confirm its effectiveness in this area. ^{1 3 4 6 7}

Who Is on the Research Team?

William Beaubien-Souligny, MD PhD

Principal Investigator

Centre Hospitalier d'Université de Montréal

Are You a Good Fit for This Trial?

This trial is for non-critically ill patients with acute kidney injury (AKI). It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need to be stable enough to undergo ultrasound evaluations and not have conditions that could interfere with the study.

Inclusion Criteria

Acute kidney injury defined by the KDIGO criteria

I am currently admitted to a hospital.

My kidney doctor has started or is considering fluid treatment for me.

Exclusion Criteria

I am currently in the intensive care unit.

I am on or will start kidney replacement therapy for acute kidney injury soon.

I have stage 5 chronic kidney disease, with or without dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive management with or without POCUS evaluation of fluid tolerance

5 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound evaluation of fluid tolerance

Trial Overview The trial tests if using Point-Of-Care ultrasound (POCUS) can better guide fluid therapy in AKI patients compared to usual care. The goal is to see if POCUS helps avoid fluid overload complications by informing treatment decisions.

How Is the Trial Designed?

Group I: Management with ultrasound information Experimental Treatment 1 Intervention

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 II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Ultrasonic Doppler examination and contrast-enhanced ultrasound effectively detect changes in renal blood flow and can help assess the prognosis of patients with septic acute kidney injury (AKI), as shown by significant differences in blood flow parameters between AKI patients and controls.

The study found that as the severity of AKI increased, certain ultrasound parameters like the peak value and time to peak (TTP) worsened, indicating a strong correlation with serum creatinine levels, which is crucial for monitoring kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of ultrasound and contrast-enhanced ultrasound in septic acute kidney injury. Liu, PQ., Ding, CW., Zhang, YC., et al.[2022]

Ultrasound can be a valuable tool in assessing acute kidney injury (AKI) by identifying reversible causes and underlying chronic kidney disease, which is crucial for effective patient management.

The study introduces the ultrasound SERVeillance framework, which focuses on assessing renal size, echogenicity, renal hilum, and vascularity to standardize the imaging evaluation of AKI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Assessment of Acute Kidney Injury. Kelahan, LC., Desser, TS., Troxell, ML., et al.[2020]

In a study of 111 patients with acute kidney injury (AKI), ultrasonography revealed that AKI patients had significantly larger kidney size and volume compared to healthy controls, indicating a potential marker for evaluating AKI.

While many AKI patients showed normal ultrasound imaging, abnormal findings such as increased parenchymal echogenicity and renal resistance index were observed, suggesting that ultrasonography can provide valuable insights beyond just identifying obstructive nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of ultrasonographic evaluation in acute kidney injury. Liu, C., Wang, X.[2022]

In a study of 778 hospitalized patients with acute kidney injury, the Licurse model effectively identified patients at risk for hydronephrosis, achieving a high sensitivity of 93.4% for detecting hydronephrosis and 91.3% for predicting urologic intervention.

Hydronephrosis was diagnosed in 13.6% of patients, leading to urologic intervention in 3.0%, suggesting that the Licurse model could help reduce unnecessary renal ultrasounds by ruling out hydronephrosis in about 22.6% of patients based on clinical predictors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of risk stratification strategy in the use of renal ultrasonography in the evaluation of acute kidney injury. Ip, IK., Silveira, PC., Alper, EC., et al.[2019]

Acute kidney injury (AKI) is a major concern in ICU patients, with over 5% requiring renal replacement therapy and mortality rates exceeding 60%, highlighting the need for effective management strategies.

Point-of-care ultrasound can significantly improve the assessment of volume status and vascular flow in critically ill patients, allowing for better identification of AKI risk factors and more tailored fluid management to optimize renal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

POCUS in Intensive Care Nephrology. Connor-Schuler, R., Suarez, J.[2023]

The CCUSG-A(KI)BCDE protocol utilizes various ultrasound techniques to diagnose and assess the risk of acute kidney injury (AKI) in critically ill patients, helping to identify hemodynamic issues related to renal injury.

By capturing the hemodynamic characteristics of the kidneys, this protocol allows for better understanding of AKI's progression and aids in developing personalized treatment strategies, improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal hemodynamic evaluation protocol based on the pathophysiological mechanism of acute kidney injury: Critical Care UltraSound Guided-A(KI)BCDE. Liu, L., Liu, D., Hu, Z., et al.[2023]

A meta-analysis of six studies involving 374 patients showed that contrast-enhanced ultrasonography (CEUS) can effectively detect early changes in renal microcirculation associated with acute kidney injury (AKI), even before serum creatinine levels rise.

CEUS parameters such as maximum intensity and wash-in rate were significantly lower in patients with AKI, while mean transit time and time to peak were higher, indicating reduced microcirculatory perfusion and prolonged perfusion time in the kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Ultrasonography for Acute Kidney Injury: A Systematic Review and Meta-Analysis. Li, Y., Chen, L., Feng, L., et al.[2023]

Contrast-enhanced ultrasound effectively detects changes in renal perfusion in dogs with acute kidney injury, showing increased medullary peak intensity and faster vascularization compared to healthy dogs.

This method is safe, non-invasive, and easy to perform, making it a valuable tool for assessing kidney health in veterinary medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhancement ultrasound of renal perfusion in dogs with acute kidney injury. Mannucci, T., Lippi, I., Rota, A., et al.[2022]

In a study involving 147 patients with shock, those managed with critical care ultrasound had significantly lower ICU mortality compared to those receiving conventional treatment, indicating improved patient outcomes.

The study found that reduced fluid intake during stabilization and de-escalation phases was associated with better prognosis, suggesting that careful fluid management guided by ultrasound can enhance recovery in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of Critical Care Ultrasound Oriented Fluid Management in Different Stages of Shock to the Outcome]. Qin, Y., Yin, WH., Zeng, XY., et al.[2020]

In a study of 33 patients with acute kidney injury (AKI) in a medical intensive care unit, using bedside ultrasound to measure the inferior vena cava (IVC) helped predict which patients would benefit from fluid management, leading to better renal function outcomes.

Patients whose fluid management aligned with their IVC measurements showed significant improvements in kidney function, with 85% showing improved creatinine levels compared to only 31% in those whose management did not align, highlighting the potential of US-IVC as a useful tool in critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IVC Measurements in Critically Ill Patients with Acute Renal Failure. Jambeih, R., Keddissi, JI., Youness, HA.[2020]

Ultrasound is a promising, noninvasive tool that can help diagnose and manage acute kidney injury (AKI) and chronic kidney disease (CKD), with recent advances enhancing its effectiveness.

The use of microbubble contrast agents in ultrasound not only improves the accuracy of kidney disease diagnosis but also allows for targeted drug delivery, potentially offering a new treatment approach for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Ultrasound Techniques Promise Further Advances in AKI and CKD. Hull, TD., Agarwal, A., Hoyt, K.[2018]

Doppler ultrasonography, specifically the renal resistive index, is a promising noninvasive tool for early detection of acute kidney injury (AKI) in ICU patients, helping to identify those at higher risk.

This method not only aids in predicting AKI but also allows for the differentiation between transient and persistent forms of the condition, potentially guiding timely interventions for kidney protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Le Dorze, M., Bouglé, A., Deruddre, S., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06411080

NCT06411080 | UltraSound Evaluation of Fluid tOleRanCE ... Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI). While it is generally ...

2. crrtonline.com crrtonline.com/conference/posters_2025/Gouin_Michel.pdf

Ultrasound Evaluation of Fluid Tolerance for Acute Kidney ... POCUS evaluation of fluid tolerance could improve outcomes in AKI. This pilot study will help assess the feasibility, explore potential barriers, and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06411080/ultrasound-evaluation-of-fluid-tolerance-for-acute-kidney-injury

UltraSound Evaluation of Fluid tOleRanCE for Acute ... Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11155499/

Point-of-care ultrasonography for acute kidney injury in cirrhosis This article delves into the intricate challenges of acute kidney injury (AKI) in cirrhosis, a condition fraught with high morbidity and mortality.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4057151/

Diagnosis, evaluation, and management of acute kidney injury The guideline is based on evidence review and appraisal, and covers AKI definition, risk assessment, evaluation, prevention, and treatment.

6. ctv.veeva.com ctv.veeva.com/study/ultrasound-evaluation-of-fluid-tolerance-for-acute-kidney-injury

UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney ... This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10520752/

Transcending boundaries: Unleashing the potential of multi ... In this review, we explore the potential of nephrologist-performed POCUS in addressing specific diagnostic and management questions in AKI patients.