Early Nephrology Intervention for Acute Kidney Injury

(ESTOP-AKI Trial)

Overseen By Sharon Trevino, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: End-stage renal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

180 Participants Needed

Trial Summary

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 Automated AKI Risk Score, Early Nephrology Consult, Standard of Care, Standard Treatment, Conventional Care, Usual Care for acute kidney injury?

Research shows that using prediction models and electronic alerts can help identify patients at risk of acute kidney injury (AKI) earlier, which can lead to timely interventions and potentially better outcomes. For example, the AKI Risk Score (AKI-RiSc) is a tool that helps identify patients at risk of AKI early, allowing for quicker medical response. ^{1 2 3 4 5}

Is early nephrology intervention for acute kidney injury safe for humans?

The research articles provided do not contain specific safety data for early nephrology intervention in acute kidney injury, but they discuss risk prediction and management tools for AKI without mentioning any safety concerns. ^{1 6 7 8 9}

How is the Automated AKI Risk Score treatment different from other treatments for acute kidney injury?

The Automated AKI Risk Score treatment is unique because it uses a machine learning model to predict acute kidney injury early, allowing for timely intervention before symptoms appear. This approach focuses on risk stratification and personalized patient profiles, which is different from traditional treatments that often address more severe stages of the condition. ^{3 5 10 11 12}

What is the purpose of this trial?

This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.

Research Team

Jay Koyner, MD

Principal Investigator

University of Chicago Medicine

Eligibility Criteria

This trial is for adults over 18 who have a risk of acute kidney injury (AKI) as indicated by an ESTOP AKI score ≥0.12. It's not open to those with end-stage renal disease, high creatinine levels at admission, previous AKI episodes or renal consultations during the same hospital stay.

Inclusion Criteria

You have a high risk for developing acute kidney injury based on a recent test score.

I am older than 18 years.

Exclusion Criteria

I had a kidney injury during this hospital stay.

I have seen a kidney specialist during my hospital stay.

I have not refused or failed to provide written consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an early nephrology consult with daily follow-up or standard care after symptoms of AKI appear

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Automated AKI Risk Score
• Early Nephrology Consult
• Standard of Care

Trial Overview The study tests if an automated real-time electronic health record risk score can improve outcomes in patients at risk of AKI through early intervention from kidney specialists compared to standard care.

Participant Groups

Group I: Early Nephrology Consult (ENC) Experimental Treatment 1 Intervention

The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations.

Group II: Standard of Care (SOC) Active Control 1 Intervention

Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

References

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

Acute kidney injury and its progression in hospitalized patients-Results from a retrospective multicentre cohort study with a digital decision support system. [2021]

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

Accurate and interpretable prediction of ICU-acquired AKI. [2023]

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

The Role of Risk Prediction Models in Prevention and Management of AKI. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Development and validation of an interpretable clinical score for early identification of acute kidney injury at the emergency department. [2022]

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

Significance of platelets in the early warning of new-onset AKI in the ICU by using supervise learning: a retrospective analysis. [2023]

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

Prediction of Mortality and Major Adverse Kidney Events in Critically Ill Patients With Acute Kidney Injury. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review of prognostic prediction models for acute kidney injury (AKI) in general hospital populations. [2022]

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

Understanding Electronic AKI Alerts: Characterization by Definitional Rules. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Risk Factors for Acute Kidney Injury in Hospitalized Non-Critically Ill Patients: A Population-Based Study. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Kidney Injury in the Surgical Patient: Recognition and Attribution. [2022]

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

Post-Acute Kidney Injury Proteinuria and Subsequent Kidney Disease Progression: The Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI) Study. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The assessment of acute kidney injury in critically ill patients. [2018]