Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Andrew Bishara, MD (ucsf)
Headshot of Andrew Bishara
Andrew Bishara

Description

Summary

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.

Official Title

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

Keywords

Acute Kidney Injury, Surgery Complications, Anesthesia, Surgical Outcomes, Machine Learning, Clinical Decision Support, Electronic Health Records, EHR-Embedded AKI Risk Score, EHR-Embedded AKI Risk Score with Best Practice Advisory

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, San Francisco
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Andrew Bishara, MD (ucsf)
    My main research aim is to better predict and prevent complications in surgical patients using advanced machine learning techniques. Real-Time Risk Assessment: Creating models to predict acute kidney injury (AKI), pain, delirium, and blood loss during surgeries in real-time. Model Validation: Ensuring these models are reliable with the eventual goal of pursuing regulatory approval.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07604662
Study Type
Interventional
Participants
Expecting 25518 study participants
Last Updated