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Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial (ML-AKI)

19 maggio 2026 aggiornato da: University of California, San Francisco

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

25518

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94158
        • University of California, San Francisco

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Arm
Participants receive usual perioperative care with a placeholder blank display without the machine learning-derived acute kidney injury (AKI) risk score. The clinical decision support tool remains hidden in the electronic health record, and no alerts or recommendations related to the study are shown.
Sperimentale: Acute Kidney Injury Risk Score Only
A machine learning-derived preoperative AKI risk score is displayed within the electronic health record for high-risk patients. A passive recommendation indicating that the patient may benefit from a KDIGO-based kidney-protective bundle is provided. The information is advisory only, and no interruptive alerts are used.
Dispositivo: EHR-Embedded AKI Risk Score
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.
Altri nomi:
  • EHR-Embedded AKI Clinical Decision Support Tool
Sperimentale: Acute Kidney Injury Risk Score with Best Practice Advisory
The machine learning-derived AKI risk score is displayed within the electronic health record for high-risk patients, accompanied by an interruptive Best Practice Advisory (BPA) that notifies providers that the patient may benefit from a KDIGO-based kidney-protective bundle. The alert is advisory only and does not mandate clinical actions.
Dispositivo: EHR-Embedded AKI Risk Score with Best Practice Advisory
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.
Altri nomi:
  • EHR-Embedded AKI Clinical Decision Support Tool

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-operative Change in Creatinine
Lasso di tempo: 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
From pre-operative baseline to 1-2 days post-operative level

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute Kidney Injury
Lasso di tempo: Operation to Post-operative Day 7
Acute Kidney Injury as defined by KDIGO
Operation to Post-operative Day 7
KDIGO Bundle Adherence
Lasso di tempo: Intra-operative
Measurement of provider adherence to KDIGO components
Intra-operative
Intra-Operative Time and Severity of Hypotension
Lasso di tempo: 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
Intra-operative
Total intra-operative intravenous fluid volume administered (mL)
Lasso di tempo: 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.
Intra-operative
Length of Stay
Lasso di tempo: Operation to Post-operative Day 180
Duration of patient admission in hospital in days
Operation to Post-operative Day 180
Intra-operative Hyperglycemic Events
Lasso di tempo: Intra-operative
Number of intra-operative hyperglycemic events, defined as the number of recorded blood glucose measurements exceeding 180 mg/dL.
Intra-operative
Intra-operative Nephrotoxin Exposure
Lasso di tempo: Intra-operative
Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure
Intra-operative
In-Hospital Mortality
Lasso di tempo: Operation to Post-operative Day 180
Patient death while admitted in the hospital
Operation to Post-operative Day 180
ICU Transfer and total time in the ICU
Lasso di tempo: Postoperative
Any transfers to the ICU while admitted and the total time the patient spends in the ICU
Postoperative
Hospital Readmission
Lasso di tempo: Operation to Post-operative Day 180
Readmission back to a UCSF hospital following operation
Operation to Post-operative Day 180
Dialysis Requirement
Lasso di tempo: Operation to Post-operative Day 180
Patients requiring dialysis following surgery
Operation to Post-operative Day 180
Dilution Corrected KDIGO AKI measurement (Stage 1 or higher)
Lasso di tempo: 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
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)
Lasso di tempo: intraoperative
Provider administration of packed red blood cells during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative fresh frozen plasma administered (units transfused)
Lasso di tempo: intraoperative
Provider administration of fresh frozen plasma during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative platelets administered (units transfused)
Lasso di tempo: intraoperative
Provider administration of platelets during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative cryoprecipitate administered (units transfused)
Lasso di tempo: intraoperative
Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.
intraoperative

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Francisco

Collaboratori

National Institute of General Medical Sciences (NIGMS)

Investigatori

  • Investigatore principale: Andrew Bishara, MD, University of California, San Francisco

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 ottobre 2026

Completamento primario (Stimato)

15 ottobre 2027

Completamento dello studio (Stimato)

15 dicembre 2027

Date di iscrizione allo studio

Primo inviato

9 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 22-37005
  • K23GM151611-03 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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