Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial (ML-AKI)
19 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Тип исследования
Интервенционный
Регистрация (Оцененный)
25518
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Andrew Bishara, MD
- Номер телефона: 415-502-5880
- Электронная почта: andrew.bishara@ucsf.edu
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94158
- University of California, San Francisco
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: 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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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Post-operative Change in Creatinine
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Acute Kidney Injury
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Andrew Bishara, MD, University of California, San Francisco
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 октября 2026 г.
Первичное завершение (Оцененный)
15 октября 2027 г.
Завершение исследования (Оцененный)
15 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
9 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
19 мая 2026 г.
Первый опубликованный (Действительный)
22 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
19 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 22-37005
- K23GM151611-03 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .