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

2026年5月19日 更新者: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.

研究概览

研究类型

介入性

注册 (估计的)

25518

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • California
      • San Francisco、California、美国、94158
        • University of California, San Francisco

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预: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.
实验性的: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.
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.
其他名称:
  • EHR-Embedded AKI Clinical Decision Support Tool
实验性的: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.
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.
其他名称:
  • EHR-Embedded AKI Clinical Decision Support Tool

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-operative Change in Creatinine
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Acute Kidney Injury
大体时间:Operation to Post-operative Day 7
Acute Kidney Injury as defined by KDIGO
Operation to Post-operative Day 7
KDIGO Bundle Adherence
大体时间:Intra-operative
Measurement of provider adherence to KDIGO components
Intra-operative
Intra-Operative Time and Severity of Hypotension
大体时间: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)
大体时间: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
大体时间:Operation to Post-operative Day 180
Duration of patient admission in hospital in days
Operation to Post-operative Day 180
Intra-operative Hyperglycemic Events
大体时间: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
大体时间:Intra-operative
Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure
Intra-operative
In-Hospital Mortality
大体时间: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
大体时间:Postoperative
Any transfers to the ICU while admitted and the total time the patient spends in the ICU
Postoperative
Hospital Readmission
大体时间:Operation to Post-operative Day 180
Readmission back to a UCSF hospital following operation
Operation to Post-operative Day 180
Dialysis Requirement
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间:intraoperative
Provider administration of platelets during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative cryoprecipitate administered (units transfused)
大体时间:intraoperative
Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.
intraoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andrew Bishara, MD、University of California, San Francisco

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月15日

初级完成 (估计的)

2027年10月15日

研究完成 (估计的)

2027年12月15日

研究注册日期

首次提交

2026年4月9日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月19日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

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