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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
25,518
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.
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.
University of California, San Francisco
San Francisco, California, United States
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
Acute Kidney Injury
Acute Kidney Injury as defined by KDIGO
Time frame: Operation to Post-operative Day 7
KDIGO Bundle Adherence
Measurement of provider adherence to KDIGO components
Time frame: Intra-operative
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
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
Length of Stay
Duration of patient admission in hospital in days
Time frame: Operation to Post-operative Day 180
Intra-operative Hyperglycemic Events
Number of intra-operative hyperglycemic events, defined as the number of recorded blood glucose measurements exceeding 180 mg/dL.
Time frame: Intra-operative
Intra-operative Nephrotoxin Exposure
Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure
Time frame: Intra-operative
In-Hospital Mortality
Patient death while admitted in the hospital
Time frame: Operation to Post-operative Day 180
ICU Transfer and total time in the ICU
Any transfers to the ICU while admitted and the total time the patient spends in the ICU
Time frame: Postoperative
Hospital Readmission
Readmission back to a UCSF hospital following operation
Time frame: Operation to Post-operative Day 180
Dialysis Requirement
Patients requiring dialysis following surgery
Time frame: Operation to Post-operative Day 180
Dilution Corrected KDIGO AKI measurement (Stage 1 or higher)
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
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.
Total intra-operative packed red blood cells administered (units transfused)
Provider administration of packed red blood cells during the intra-operative period, measured as total units transfused.
Time frame: intraoperative
Total intra-operative fresh frozen plasma administered (units transfused)
Provider administration of fresh frozen plasma during the intra-operative period, measured as total units transfused.
Time frame: intraoperative
Total intra-operative platelets administered (units transfused)
Provider administration of platelets during the intra-operative period, measured as total units transfused.
Time frame: intraoperative
Total intra-operative cryoprecipitate administered (units transfused)
Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.
Time frame: intraoperative
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