Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial (ML-AKI)
19. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Intervenční
Zápis (Odhadovaný)
25518
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Andrew Bishara, MD
- Telefonní číslo: 415-502-5880
- E-mail: andrew.bishara@ucsf.edu
Studijní místa
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California
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San Francisco, California, Spojené státy, 94158
- University of California, San Francisco
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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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Experimentální: 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.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Post-operative Change in Creatinine
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Acute Kidney Injury
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Andrew Bishara, MD, University of California, San Francisco
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. října 2026
Primární dokončení (Odhadovaný)
15. října 2027
Dokončení studie (Odhadovaný)
15. prosince 2027
Termíny zápisu do studia
První předloženo
9. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
19. května 2026
První zveřejněno (Aktuální)
22. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 22-37005
- K23GM151611-03 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
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produkt vyrobený a vyvážený z USA
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