AKI Alerts for Acute Kidney Injury

Overseen By Francis P Wilson, MD MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Dialysis, ESKD, Kidney transplant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sending alerts to doctors can prevent acute kidney injury (AKI) from worsening, reduce the need for dialysis, and lower the risk of death. Participants will be divided into two groups: one where electronic health record alerts for AKI are sent to doctors if a patient is expected to benefit, and another where alerts are not sent even if a benefit is expected. The trial seeks adults in the hospital who have recently shown signs of worsening kidney function, such as a significant increase in a specific blood test over a short period. Hospitalized individuals with AKI should consider these criteria to determine eligibility. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve patient care.

Do I have to stop taking my current medications for the AKI Alerts trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research has shown that electronic alerts for acute kidney injury (AKI) can impact patient outcomes. Some studies have found that these alerts help reduce severe AKI cases and improve recovery rates, suggesting they generally support better kidney health.

However, results are mixed. In some hospitals, alerts were linked to worse outcomes, possibly due to how hospitals used them. The safety of the alert system depends on hospital implementation and response. While no reports indicate direct harm from the alerts themselves, their effectiveness can vary.

In summary, while alerts show promise in some settings, their impact can differ based on hospital practices. No direct safety concerns for patients have been noted, but effectiveness can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AKI Alerts trial because it explores a novel approach in managing Acute Kidney Injury (AKI) through predictive alerts rather than traditional medication or dialysis. Unlike standard treatments that focus on responding to kidney injury after it occurs, this trial examines whether real-time alerts, based on a probability score, can proactively identify patients likely to benefit from early intervention. This innovative use of technology aims to prevent kidney damage before it progresses, potentially transforming how AKI is managed and improving patient outcomes by focusing on prevention rather than just treatment.

What evidence suggests that this trial's AKI alert treatments could be effective?

Research has shown that electronic alerts for acute kidney injury (AKI) have not consistently reduced the worsening of AKI, the need for dialysis, or the risk of death. One study found that 21.3% of patients who received alerts experienced the main negative outcome, similar to 20.9% of those who did not receive alerts. A review of multiple studies found no clear improvement in patient survival or kidney health due to these alerts. While alerts have led to some changes in medical practices, they have not been proven to improve kidney function or other important patient outcomes. Therefore, current evidence leaves the effectiveness of AKI alerts uncertain. This trial will compare two approaches: one arm will generate alerts for patients with a probability of benefit greater than 0.5, while the other arm will generate alerts for those with a probability of benefit less than 0.5. ^{1 2 4 6 7}

Who Is on the Research Team?

Francis Wilson, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized and have acute kidney injury (AKI) as shown by a significant rise in creatinine levels. It's not open to those already on dialysis, with very high initial creatinine, previous participation, hospice care, recent kidney transplant or opted out of health record research.

Inclusion Criteria

Admitted to a participating hospital

Your kidney function has declined based on specific levels of creatinine in your blood during a short period of time.

Exclusion Criteria

I was prescribed dialysis before my acute kidney injury.

I am currently enrolled in hospice care or receiving comfort-only treatments.

I had a kidney transplant less than 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Intervention

Participants are randomized into 'recommended' or 'anti-recommended' groups based on uplift scores, and alerts are generated accordingly

14 days

Inpatient monitoring

Follow-up

Participants are monitored for AKI progression, dialysis, or mortality

14 days

Extended Follow-up

Participants are monitored for secondary outcomes such as AKI best practices and readmission rates

Up to one year

What Are the Treatments Tested in This Trial?

Interventions

• Alert

Trial Overview The study tests if targeting AKI alerts using uplift modeling to patients most likely to benefit can reduce the worsening of AKI, need for dialysis, or death. The alert aims to prompt timely medical response when a patient's condition indicates risk.

How Is the Trial Designed?

Group I: Recommended Experimental Treatment 1 Intervention

Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert.

Group II: Anti-recommended Experimental Treatment 1 Intervention

Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The introduction of electronic alerts for Acute Kidney Injury (AKI) significantly reduced the progression to higher AKI stages, emergency readmissions, and in-hospital deaths, indicating improved patient safety.

Following the e-alert implementation, there was an increase in the appropriate management of AKI, including more frequent stopping of high-risk drug prescriptions and increased ICU admissions, suggesting enhanced clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does acute kidney injury alerting improve patient outcomes? Atia, J., Evison, F., Gallier, S., et al.[2023]

In a study involving 2413 hospitalized patients with acute kidney injury, the implementation of an automated electronic alert system did not lead to improved clinical outcomes, such as changes in creatinine levels, dialysis rates, or mortality, compared to usual care.

The results showed no significant differences in the severity of kidney injury or patient outcomes at 7 days, indicating that the alert system may not be effective in enhancing the management of acute kidney injury in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Wilson, FP., Shashaty, M., Testani, J., et al.[2023]

The implementation of an AKI alert system at Brandenburg Hospital did not significantly improve key outcomes such as in-hospital mortality or kidney function recovery in patients with acute kidney injury, despite a higher rate of correct alerts in the second period.

However, the need for kidney replacement therapy increased significantly from 14% in the first period to 34.4% in the second period, suggesting that while the alert system did not improve overall outcomes, it may have led to more aggressive management of AKI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic acute kidney injury alert at the Brandenburg Medical School - implementation and follow-up. Assem, A., Safi, W., Ritter, O., et al.[2023]

The introduction of automated acute kidney injury (AKI) electronic alerts in the Tayside region did not significantly change the rate or severity of AKI, nor did it improve 30-day mortality rates among patients with AKI, based on an analysis of 32,320 episodes over four years.

However, there was a small reduction in the number of occupied hospital bed days per patient, suggesting that while the alerts did not enhance clinical outcomes, they may have contributed to more efficient hospital resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of electronic alerts for acute kidney injury on patient outcomes: interrupted time-series analysis of population cohort data. Baird, D., De Souza, N., Logan, R., et al.[2022]

The implementation of a digitally enabled intervention for detecting and managing acute kidney injury (AKI) in hospitalized patients did not improve the primary outcome of renal function recovery by discharge, indicating that the intervention may need further refinement to enhance clinical effectiveness.

However, the intervention was associated with a significant reduction in healthcare costs by £2123 per patient and a notable decrease in the hospital-wide cardiac arrest rate, suggesting potential benefits in patient safety and cost efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Digitally Enabled Care Pathway (Part 1): Impact on Clinical Outcomes and Associated Health Care Costs. Connell, A., Raine, R., Martin, P., et al.[2023]

A systematic review of six studies involving 10,165 hospitalized patients found that electronic alerts (e-alerts) for acute kidney injury (AKI) did not significantly improve patient mortality or reduce the need for renal replacement therapy.

While some isolated studies showed improvements in specific care processes, the overall impact of e-alerts on patient outcomes was minimal, indicating a need for further research to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between e-alert implementation for detection of acute kidney injury and outcomes: a systematic review. Lachance, P., Villeneuve, PM., Rewa, OG., et al.[2022]

The implementation of a national electronic alert system for acute kidney injury (AKI) led to a significant decrease in 30-day mortality rates over four years, with a notable reduction in mortality from Year 1 to Year 4, indicating improved patient outcomes.

The study, which analyzed 193,838 AKI episodes in 132,599 patients, found that the alert system was particularly effective in community-acquired AKI cases, resulting in increased hospitalizations and better management of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute kidney injury demographics and outcomes: changes following introduction of electronic acute kidney injury alerts-an analysis of a national dataset. Holmes, J., Donovan, K., Geen, J., et al.[2021]

Recent advances in electronic alerts (e-alerts) for acute kidney injury (AKI) have shown promise, particularly with the implementation of a standardized detection algorithm in England that has demonstrated good diagnostic performance.

However, a recent randomized trial indicated that simply using text message e-alerts did not significantly change clinician behavior or improve patient outcomes, highlighting the need for effective communication methods and further research on interventions that can influence clinician actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in electronic alerts for acute kidney injury. Horne, KL., Selby, NM.[2022]

Current randomized trials indicate that electronic alerts (eAlerts) for acute kidney injury (AKI) do not significantly reduce mortality rates, suggesting that while they are useful, they may not directly save lives.

However, eAlerts have shown potential in reducing the incidence, progression, and duration of AKI, indicating that they can improve the overall management and care of patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic alerts in acute kidney injury: why does evidence of benefit remain elusive? Horne, K., Noble, R., Karelia, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034420/

Electronic health record alerts for acute kidney injury The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33461986/

Electronic health record alerts for acute kidney injury - PubMed Conclusions: Alerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822866

Electronic Alert Systems for Patients With Acute Kidney Injury This meta-analysis assesses the association between electronic alerts and patient survival, kidney outcomes, clinical practice patterns, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S246802492402206X

WCN25-3547 Impact of Using Automated Electronic Alert ... The purpose of this study is to systematically review and analyze the impact of e-alerts on AKI management outcomes in hospitalized patients.

5. 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 ...

6. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03639-x

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

7. ovid.com ovid.com/journals/bmjd/abstract/10.1136/bmj.m4786~electronic-health-record-alerts-for-acute-kidney-injury

Electronic health record alerts for acute kidney injury Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary ...