Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial (ML-AKI)
19 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
25518
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Andrew Bishara, MD
- Número de teléfono: 415-502-5880
- Correo electrónico: andrew.bishara@ucsf.edu
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94158
- University of California, San Francisco
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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.
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Experimental: 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.
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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.
Otros nombres:
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Experimental: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Post-operative Change in Creatinine
Periodo de tiempo: From pre-operative baseline to 1-2 days post-operative level
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Maximum continuous change in serum creatinine (mg/dL) from baseline to post-operative day 1-2
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From pre-operative baseline to 1-2 days post-operative level
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute Kidney Injury
Periodo de tiempo: Operation to Post-operative Day 7
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Acute Kidney Injury as defined by KDIGO
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Operation to Post-operative Day 7
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KDIGO Bundle Adherence
Periodo de tiempo: Intra-operative
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Measurement of provider adherence to KDIGO components
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Intra-operative
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Intra-Operative Time and Severity of Hypotension
Periodo de tiempo: Intra-operative
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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
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Intra-operative
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Total intra-operative intravenous fluid volume administered (mL)
Periodo de tiempo: Intra-operative
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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.
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Intra-operative
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Length of Stay
Periodo de tiempo: Operation to Post-operative Day 180
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Duration of patient admission in hospital in days
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Operation to Post-operative Day 180
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Intra-operative Hyperglycemic Events
Periodo de tiempo: Intra-operative
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Number of intra-operative hyperglycemic events, defined as the number of recorded blood glucose measurements exceeding 180 mg/dL.
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Intra-operative
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Intra-operative Nephrotoxin Exposure
Periodo de tiempo: Intra-operative
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Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure
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Intra-operative
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In-Hospital Mortality
Periodo de tiempo: Operation to Post-operative Day 180
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Patient death while admitted in the hospital
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Operation to Post-operative Day 180
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ICU Transfer and total time in the ICU
Periodo de tiempo: Postoperative
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Any transfers to the ICU while admitted and the total time the patient spends in the ICU
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Postoperative
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Hospital Readmission
Periodo de tiempo: Operation to Post-operative Day 180
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Readmission back to a UCSF hospital following operation
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Operation to Post-operative Day 180
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Dialysis Requirement
Periodo de tiempo: Operation to Post-operative Day 180
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Patients requiring dialysis following surgery
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Operation to Post-operative Day 180
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Dilution Corrected KDIGO AKI measurement (Stage 1 or higher)
Periodo de tiempo: 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.
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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:
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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.
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Total intra-operative packed red blood cells administered (units transfused)
Periodo de tiempo: intraoperative
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Provider administration of packed red blood cells during the intra-operative period, measured as total units transfused.
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intraoperative
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Total intra-operative fresh frozen plasma administered (units transfused)
Periodo de tiempo: intraoperative
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Provider administration of fresh frozen plasma during the intra-operative period, measured as total units transfused.
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intraoperative
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Total intra-operative platelets administered (units transfused)
Periodo de tiempo: intraoperative
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Provider administration of platelets during the intra-operative period, measured as total units transfused.
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intraoperative
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Total intra-operative cryoprecipitate administered (units transfused)
Periodo de tiempo: intraoperative
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Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.
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intraoperative
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrew Bishara, MD, University of California, San Francisco
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
- Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Kork F, Balzer F, Spies CD, Wernecke KD, Ginde AA, Jankowski J, Eltzschig HK. Minor Postoperative Increases of Creatinine Are Associated with Higher Mortality and Longer Hospital Length of Stay in Surgical Patients. Anesthesiology. 2015 Dec;123(6):1301-11. doi: 10.1097/ALN.0000000000000891.
- Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.
- James MT, Dixon E, Tan Z, Mathura P, Datta I, Lall RN, Landry J, Minty EP, Samis GA, Winkelaar GB, Pannu N. Stepped-Wedge Trial of Decision Support for Acute Kidney Injury on Surgical Units. Kidney Int Rep. 2024 Jul 31;9(10):2996-3005. doi: 10.1016/j.ekir.2024.07.025. eCollection 2024 Oct.
- Fujii T, Takakura M, Taniguchi T, Tamura T, Nishiwaki K. Intraoperative hypotension affects postoperative acute kidney injury depending on the invasiveness of abdominal surgery: A retrospective cohort study. Medicine (Baltimore). 2023 Dec 1;102(48):e36465. doi: 10.1097/MD.0000000000036465.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de octubre de 2026
Finalización primaria (Estimado)
15 de octubre de 2027
Finalización del estudio (Estimado)
15 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 22-37005
- K23GM151611-03 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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