Ultrasound Evaluation for Acute Kidney Injury

(USE-the-FORCE Trial)

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

80 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment 'Ultrasound evaluation of fluid tolerance' for acute kidney injury?

Research suggests that using ultrasound to evaluate fluid tolerance can help manage acute kidney injury (AKI) by providing a more accurate assessment of fluid status and vascular flow patterns, which is crucial for individualizing treatment and preventing complications like volume overload. ^{1 2 3 4 5}

Is ultrasound evaluation for acute kidney injury safe for humans?

Ultrasound evaluation, including techniques like contrast-enhanced ultrasound, is generally considered safe for assessing acute kidney injury in humans. It helps doctors understand kidney function and blood flow without invasive procedures. ^{1 5 6 7 8}

How does ultrasound evaluation of fluid tolerance differ from other treatments for acute kidney injury?

Ultrasound evaluation of fluid tolerance is unique because it uses imaging to assess how well the body can handle fluids, helping to guide treatment decisions. Unlike other treatments that may rely on less precise measures, this approach provides a more accurate picture of fluid status and kidney function, allowing for personalized management of acute kidney injury. ^{1 9 10 11 12}

Research Team

William Beaubien-Souligny, MD PhD

Principal Investigator

Centre Hospitalier d'Université de Montréal

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

POCUS in Intensive Care Nephrology. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Influence of Critical Care Ultrasound Oriented Fluid Management in Different Stages of Shock to the Outcome]. [2020]

3. Egypt pubmed.ncbi.nlm.nih.gov

IVC Measurements in Critically Ill Patients with Acute Renal Failure. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

New Ultrasound Techniques Promise Further Advances in AKI and CKD. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Ultrasonography for Acute Kidney Injury: A Systematic Review and Meta-Analysis. [2023]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnostic value of ultrasound and contrast-enhanced ultrasound in septic acute kidney injury. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Contrast enhancement ultrasound of renal perfusion in dogs with acute kidney injury. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound Assessment of Acute Kidney Injury. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. [2016]

11. China pubmed.ncbi.nlm.nih.gov

Clinical utility of ultrasonographic evaluation in acute kidney injury. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

External validation of risk stratification strategy in the use of renal ultrasonography in the evaluation of acute kidney injury. [2019]