Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Obstetric procedures.

Chronic dialysis patients.

Kidney transplant recipients.

Cases without baseline creatinine/eGFR or missing essential EHR elements needed for scoring/outcomes (operational exclusions).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

25,518 Participants
are divided into 3 treatment groups
Group A: Control ArmNo intervention 0 interventions
Group B: Acute Kidney Injury Risk Score OnlyExperimental treatment 1 intervention
Group C: Acute Kidney Injury Risk Score with Best Practice AdvisoryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative Change in Creatinine

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

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

Secondary outcomes

1

Acute Kidney Injury

Acute Kidney Injury as defined by KDIGO

Time frame
Operation to Post-operative Day 7
2

KDIGO Bundle Adherence

Measurement of provider adherence to KDIGO components

Time frame
Intra-operative
3

Intra-Operative Time and Severity of Hypotension

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

Time frame
Intra-operative
4

Total intra-operative intravenous fluid volume administered (mL)

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.

Time frame
Intra-operative

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

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