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NCT Number: NCT07604662

Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial

This investigator-initiated, pragmatic trial evaluates whether displaying a machine learning (ML)- derived perioperative AKI risk score-alone or paired with an interruptive Best/Our Practice Advisory (BPA/OPA)-improves kidney-protective care and reduces kidney injury after non-obstetric surgery at UCSF. Approximately 75-100 attending anesthesiologists (clusters) are randomized 1:1:1 to: (a) Control (risk score hidden), (b) Score Only (visible preoperative AKI risk probability with passive KDIGO bundle recommendation), or (c) Score + BPA (visible risk plus interruptive KDIGO prompt for high-risk patients). CRNAs/residents follow their attending' s assignment. Adult inpatients (age ≥18) with expected overnight stay and eGFR ≥15 mL/min/1.73 m² are included; obstetrics, chronic dialysis, and kidney transplant patients are excluded. The underlying preoperative model was prospectively validated at UCSF and outperforms anesthesiologist risk estimation reported in the literature. The model was reviewed and approved by the AI Oversight Committee at UCSF. Primary endpoint is the continuous change in serum creatinine (mg/dL) from baseline to POD 1-2. Secondary outcomes include KDIGO-defined AKI, adherence to bundle elements (hemodynamics, balanced fluids, nephrotoxin avoidance, glycemic control), intraoperative hypotension time, fluid volumes, nephrotoxin exposure, perioperative hyperglycemia, length of stay, unplanned ICU transfer, readmission, dialysis, and in-hospital mortality. Data are obtained from the EHR; analysts are blinded. No direct subject interaction is planned; the investigators will request a waiver of patient consent. The study aims to demonstrate that ML-enabled, workflow-embedded decision support can safely and feasibly improve guideline concordant care and decrease early postoperative kidney injury.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults ≥18 years undergoing non-obstetric surgery at UCSF.
  • Inpatient cases with expected overnight stay.
  • Baseline eGFR ≥15 mL/min/1.73 m².
  • Managed by an attending anesthesiologist randomized to one of three arms (CRNAs/residents follow attending).
  • Data available in the UCSF EHR for risk scoring and outcomes.

Exclusion criteria

  • Obstetric procedures.
  • Chronic dialysis patients.
  • Kidney transplant recipients.
  • Cases without baseline creatinine/eGFR or missing essential EHR elements needed for scoring/outcomes (operational exclusions).
  • Outpatient procedures without expected overnight stay.

Treatment and study plan

EHR-Embedded AKI Risk Score

Device

A non-adaptive, machine learning-based clinical decision support tool integrated into the electronic health record that generates a preoperative probability of acute kidney injury (AKI) using routinely collected patient data. For patients identified as high risk, the tool displays the risk estimate to anesthesia providers without an accompanying Best Practice Advisory (BPA) recommending consideration of a KDIGO-based kidney-protective bundle. The intervention is advisory only, does not mandate clinical actions, and is designed to support provider decision-making within the existing clinical workflow.

Other names: EHR-Embedded AKI Clinical Decision Support Tool

EHR-Embedded AKI Risk Score with Best Practice Advisory

Device

A non-adaptive, machine learning-based clinical decision support tool integrated into the electronic health record that generates a preoperative probability of acute kidney injury (AKI) using routinely collected patient data. For patients identified as high risk, the tool displays the risk estimate to anesthesia providers with an accompanying Best Practice Advisory (BPA) recommending consideration of a KDIGO-based kidney-protective bundle. The intervention is advisory only, does not mandate clinical actions, and is designed to support provider decision-making within the existing clinical workflow.

Other names: EHR-Embedded AKI Clinical Decision Support Tool

Primary outcomes

  1. Post-operative Change in Creatinine

    Time frame: From pre-operative baseline to 1-2 days post-operative level

    Maximum continuous change in serum creatinine (mg/dL) from baseline to post-operative day 1-2

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: Operation to Post-operative Day 7

    Acute Kidney Injury as defined by KDIGO

  2. KDIGO Bundle Adherence

    Time frame: Intra-operative

    Measurement of provider adherence to KDIGO components

  3. Intra-Operative Time and Severity of Hypotension

    Time frame: Intra-operative

    Intra-Operative Time and Severity (meaning how far below the threshold) where patient is in hypotension, defined as systolic blood pressure <90 mmHg and mean arterial pressure <65 mmHg during surgery

  4. Total intra-operative intravenous fluid volume administered (mL)

    Time frame: Intra-operative

    Provider administration of intravenous fluids during the intra-operative period, measured in milliliters (mL). Intravenous fluids include normal saline, lactated Ringer's, Plasma-Lyte, other balanced crystalloids, and colloid solutions such as albumin.

  5. Length of Stay

    Time frame: Operation to Post-operative Day 180

    Duration of patient admission in hospital in days

  6. Intra-operative Hyperglycemic Events

    Time frame: Intra-operative

    Number of intra-operative hyperglycemic events, defined as the number of recorded blood glucose measurements exceeding 180 mg/dL.

  7. Intra-operative Nephrotoxin Exposure

    Time frame: Intra-operative

    Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure

  8. In-Hospital Mortality

    Time frame: Operation to Post-operative Day 180

    Patient death while admitted in the hospital

  9. ICU Transfer and total time in the ICU

    Time frame: Postoperative

    Any transfers to the ICU while admitted and the total time the patient spends in the ICU

  10. Hospital Readmission

    Time frame: Operation to Post-operative Day 180

    Readmission back to a UCSF hospital following operation

  11. Dialysis Requirement

    Time frame: Operation to Post-operative Day 180

    Patients requiring dialysis following surgery

  12. Dilution Corrected KDIGO AKI measurement (Stage 1 or higher)

    Time frame: AKI is defined per KDIGO as corrected creatinine increase ≥0.3 mg/dL within 48 hours or ≥1.5× baseline within 7 days. This measure captures "hidden AKI" - kidney injury masked by fluid dilution that would be missed using standard uncorrected creatinine.

    Acute kidney injury (AKI) assessed using KDIGO creatinine criteria applied to dilution-corrected postoperative serum creatinine. Creatinine is corrected for hemodilution from perioperative fluid retention using the formula:

    Corrected Creatinine (mg/dL) = Measured Creatinine × (1 + Net Fluid Balance / Total Body Water)

    Where:

    • Net Fluid Balance (L) = Fluid inputs - urine output - blood loss - other outputs
    • Total Body Water (L) = 0.6 × weight (kg) for males; 0.5 × weight (kg) for females

  13. Total intra-operative packed red blood cells administered (units transfused)

    Time frame: intraoperative

    Provider administration of packed red blood cells during the intra-operative period, measured as total units transfused.

  14. Total intra-operative fresh frozen plasma administered (units transfused)

    Time frame: intraoperative

    Provider administration of fresh frozen plasma during the intra-operative period, measured as total units transfused.

  15. Total intra-operative platelets administered (units transfused)

    Time frame: intraoperative

    Provider administration of platelets during the intra-operative period, measured as total units transfused.

  16. Total intra-operative cryoprecipitate administered (units transfused)

    Time frame: intraoperative

    Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Bishara, MD

CONTACT

[email protected]

415-502-5880

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Prediction of Acute Kidney Injury (AKI) After Surgery: A Pragmatic Three-Arm Cluster-Randomized Trial

Acronym: ML-AKI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 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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