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NCT07604662 · ClinicalTrials.gov registry record · NA
Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial
A NA study, sponsored by University of California, San Francisco.
- Not yet
- Registry status
- NA
- Development phase
- 25,518
- Enrollment target
NCT07604662 is a NA study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 25,518 participants.
The verdict
NCT07604662, a NA study, has not yet begun recruiting, sponsored by University of California, San Francisco.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 25,518 participants
- Enrollment target
Study 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.
Interventions
- DEVICE EHR-Embedded AKI Risk Score
- DEVICE EHR-Embedded AKI Risk Score with Best Practice Advisory
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,518 participants |
| Start Date | 2026-10-15 |
| Est. Completion | 2027-12-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07604662
The ClinicalTrials.gov registry entry for NCT07604662 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 25,518 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EHR-Embedded AKI Risk Score is the first listed.
NCT07604662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07604662 about?
NCT07604662 is a clinical study titled "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 U...
What is the current status of trial NCT07604662?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 25,518 participants. The study started on 2026-10-15. Estimated completion is 2027-12-15.
What interventions are being tested in trial NCT07604662?
The interventions under investigation include: EHR-Embedded AKI Risk Score (DEVICE), EHR-Embedded AKI Risk Score with Best Practice Advisory (DEVICE).
Who is sponsoring clinical trial NCT07604662?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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