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

19 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

25518

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94158
        • University of California, San Francisco

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Triagem
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
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.
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.
Outros nomes:
  • EHR-Embedded AKI Clinical Decision Support Tool
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.
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.
Outros nomes:
  • EHR-Embedded AKI Clinical Decision Support Tool

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Post-operative Change in Creatinine
Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of California, San Francisco

Colaboradores

National Institute of General Medical Sciences (NIGMS)

Investigadores

  • Investigador principal: Andrew Bishara, MD, University of California, San Francisco

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de outubro de 2026

Conclusão Primária (Estimado)

15 de outubro de 2027

Conclusão do estudo (Estimado)

15 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

9 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 22-37005
  • K23GM151611-03 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

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