Prospective Validation of AKI Prediction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: 30 Days — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Validation of AKI Prediction Algorithm
Overview
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.
Primary outcome measures
- Acute Kidney Injury (AKI) within the first 72 hours of ICU admission [Time frame: Within 72 hours following ICU Admission]
Secondary outcome measures (2)
- Prediction Accuracy and Timeliness of AKI Risk using a Predictive Model [Time frame: Within 12 hours of ICU Admission]
- Risk of Mortality in Patients with Acute Kidney Injury (AKI) [Time frame: 28 Days following ICU admission]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Golisano Children's Hospital at Strong — Rochester
Identifiers
NCT: NCT06804200 · STUDY00008612 · K23DK138299