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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an automated system predicting the risk of Acute Kidney Injury (AKI) can enhance patient care by involving kidney specialists sooner. It compares two approaches: one where patients receive an early nephrology consult with detailed recommendations, and another where patients receive usual care after AKI symptoms appear. The trial seeks participants who have been hospitalized, have a recent AKI risk score, and have not experienced kidney failure requiring dialysis. It may suit those with kidney concerns during their hospital stay who have not yet consulted a kidney specialist. As an unphased trial, this study allows participants to contribute to innovative research that could improve early intervention strategies for AKI.

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 automated AKI risk score is safe?

Research has shown that early consultation with a kidney specialist can benefit individuals with sudden kidney problems. Studies have found that early involvement of a kidney doctor does not increase the risk of death compared to those who delay consultation. Additionally, early visits to a kidney specialist do not lead to new health issues.

One study examined the use of an automatic alert system to detect kidney issues. Although this system did not significantly improve kidney function or other health outcomes, it did not harm patients. This indicates that using technology to identify risks and promote early treatment is safe for patients.

In summary, both early visits to kidney specialists and automatic alert systems are generally safe and well-tolerated, with no major reports of negative effects from these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Nephrology Intervention for Acute Kidney Injury because it offers a proactive approach with its Automated AKI Risk Score. Unlike the standard care where nephrology consultation happens after symptoms appear, this approach provides early, structured consultative notes and daily recommendations which could lead to better outcomes. By focusing on early identification and intervention, it aims to improve patient management before the condition worsens, potentially reducing complications and enhancing recovery time.

What evidence suggests that this trial's treatments could be effective for acute kidney injury?

Research has shown that electronic alerts for Acute Kidney Injury (AKI), such as the Automated AKI Risk Score studied in this trial, can help doctors detect the problem sooner. Early detection might lead to faster treatment, potentially improving patient health. However, the effectiveness of these alerts remains uncertain, as some studies have found no improvement in kidney function or patient-focused outcomes.

In contrast, the Early Nephrology Consult (ENC), another treatment arm in this trial, has shown promise in improving outcomes for AKI patients, particularly those in intensive care. These consultations have been associated with a lower risk of in-hospital death, highlighting the potential benefits of involving kidney experts sooner. Overall, both methods in this trial aim to detect and treat AKI early, but early consultations with kidney specialists have consistently shown better results in studies. ^{3 6 7 8 9}

Who Is on the Research Team?

Jay Koyner, MD

Principal Investigator

University of Chicago Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259199/

Artificial Intelligence in Acute Kidney Injury Prediction - PMC Several AI techniques have been employed to improve the ability to detect AKI across a variety of hospitalized settings. This review discusses the evolutions of ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814092

Automated Electronic Alert for the Care and Outcomes of ... Results of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415986/

Effect of electronic alerts on the care and outcomes in ... Electronic alerts increased the incidence of AKI and dialysis in AKI patients, which likely reflected improved recognition and early intervention.

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05402-x

The influence of electronic AKI alert on prognosis of adult ... Electronic alerts for AKI aimed to assist physicians in early diagnosis and intervention, though evidence for their effectiveness is inconsistent.

5. nature.com nature.com/articles/s41467-023-39474-6

Predicting in-hospital outcomes of patients with acute ... Among them, patients with AKI stage 3 and those receiving renal replacement treatment had a mortality rate of 42% and 46%, respectively. Two ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21765052/

Early nephrology consultation can have an impact on ... The mortality rate was similar to AKI patients who were not evaluated. Nephrology consultation was delayed (≥ 48 h) in 62.3% (median time to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11838846/

Nephrology consultation improves the clinical outcomes of ... Supplementary data are available at Kidney Research and ... Early nephrology consultation can have an impact on outcome of acute kidney injury patients.

8. academic.oup.com academic.oup.com/ndt/article/26/10/3202/1906198

Early nephrology consultation can have an impact on outcome ... The mortality rate was similar to AKI patients who were not evaluated. Nephrology consultation was delayed (≥48 h) in 62.3% (median time to ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03590028

NCT03590028 | An Early Real-Time Electronic Health ... 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 ...