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

19. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

25518

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94158
        • University of California, San Francisco

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Gerät: 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.
Andere Namen:
  • 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.
Gerät: 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.
Andere Namen:
  • EHR-Embedded AKI Clinical Decision Support Tool

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-operative Change in Creatinine
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Mitarbeiter

National Institute of General Medical Sciences (NIGMS)

Ermittler

  • Hauptermittler: Andrew Bishara, MD, University of California, San Francisco

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Oktober 2026

Primärer Abschluss (Geschätzt)

15. Oktober 2027

Studienabschluss (Geschätzt)

15. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

9. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 22-37005
  • K23GM151611-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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