Clinical trial NCT06804200: Prospective Validation of AKI Prediction
Official title: Prospective Validation of AKI Prediction Algorithm
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Keywords: Machine Learning
Pediatrics
Critical Care
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-02-03
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All medical and surgical patients admitted to the pediatric intensive care unit and pediatric cardiac intensive care unit.

Brief summary: The purpose of this prospective observational study is to implement, deploy, and quantify accuracy of an existing Pediatric Early AKI Risk Score algorithm. The implementation will be facilitated using a Health Level 7 (HL7) Fast Healthcare Interoperability Resource (FHIR)-based architecture. Investigators will deploy this model and store results in a manner not viewable to the clinical team caring for the patient. To determine the accuracy of the implemented prediction model, Investigators will prospectively identify patients with AKI at 72 hours following ICU admission. Investigators hypothesize that this model will prospectively detect AKI with a sensitivity \>70% and a positive predictive value \>20%, both chosen a priori as 10% improvement over the initial Pediatric AKI Risk Score tool.

Detailed description: This is a single-center prospective observational study validating an AKI predictive model. Each model feature will be mapped to an appropriate FHIR-based resource. To mitigate the latency issues seen in other distributed CDS systems, Investigators have developed an asynchronous design where algorithm calculations are performed offline (e.g., not within the EHR) and risk scores are subsequently written back to the EHR. Importantly, in this deployment, model output and resulting clinical risk score will not be communicated to the treating clinicians.

During the study period, Investigators will review charts daily for all patients admitted to the Golisano Children's Hospital PICU, a 12-bed facility adjacent to our 15-bed Pediatric Cardiac Intensive Care Unit (PCICU). Using a standard protocol to screen and identify patients by chart review, Investigators will generate a list of patients who meet AKI KDIGO criteria by SCr and urine output, along with recorded clinical information about these patients. At the conclusion of the study period, this list will be used as the "gold standard" and compared to the automated screening tool to determine the tool's test characteristics.

Model assessment outcomes include sensitivity, positive predictive value (PPV), and number needed to alert (NNA) to prospectively identify AKI in a population of critically ill children. Additional outcomes include timeliness of identification based on model implementation (e.g., measured timestamps of algorithm prediction compared to manual, prospectively identified AKI development). Additionally, Investigators will report interventions and clinical outcomes of the prospectively identified patients with AKI, stratified by those predicted early by the model (within 24 hours of admission) versus not.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Pediatric Intensive Care Unit or Pediatric Cardiac Intensive Care Unit
* Age \> 30 days and \< 18 years

Exclusion Criteria:

* Discharged less than 12 hours after admission
* AKI at 12 hours of admission by KDIGO Serum Criteria

Primary outcomes:
measure: Acute Kidney Injury (AKI) within the first 72 hours of ICU admission
timeFrame: Within 72 hours following ICU Admission
Secondary outcomes:
measure: Prediction Accuracy and Timeliness of AKI Risk using a Predictive Model
timeFrame: Within 12 hours of ICU Admission
measure: Risk of Mortality in Patients with Acute Kidney Injury (AKI)
timeFrame: 28 Days following ICU admission
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Golisano Children's Hospital at Strong
state: New York
Study officials:
References: