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NCT Number: NCT03590028

An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years old
  • Initial ESTOP AKI score ≥0.01 within the last 8 hours.

Exclusion criteria

  • Voluntary refusal or missing written consent of the patient / legal representative.
  • Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
  • Patients without a measured serum creatinine value during their inpatient stay.
  • Patients with a creatinine >4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
  • Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
  • Patients with prior renal consultation during their admission.

Treatment and study plan

Early Nephrology Consult (ENC)

Other

The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization.

Standard of Care (SOC)

Other

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

Primary outcomes

  1. Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval

    Time frame: 7-day interval

    The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups.

Other outcomes

  1. Differences by treatment group in the proportion by percent and time in days to specified medical events.

    Time frame: 3 months

    The differences will be measured by treatment group in the proportion and time to event of patients who a) develop > Stage 2 AKI, b) require renal replacement therapy (RRT), c) undergo intensive care unit (ICU) transfer, and/or d) require non-research nephrology consult.

  2. Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.

    Time frame: 3 months

    The differences will be measured by treatment group in the proportion by percent and time in days of LOS in the hospital.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention

Acronym: ESTOP-AKI

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2018
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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