Prospective Validation of AKI Prediction

Part of paid clinical trials in Rochester, New York.

Sponsor
Adam C Dziorny
Study ID
NCT06804200
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
30 Days - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Pediatric ICU Admissions
    The study subjects are all patients admitted to the pediatric intensive care unit and the pediatric cardiac care unit at Golisano Children's Hospital at Strong. By virtue of admission to a pediatric hospital bed, all subjects will be children. The rationale for focusing on this population is that the developed algorithm focuses on identifying acute kidney injury among critically ill pediatric patients. The gender and age of subjects will not influence enrollment. To accurately determine algorithm test characteristics (sensitivity, PPV, NNA) pragmatically, Investigators must include all admitted patients. Missing patients may bias our results and invalidate the study.

Primary Outcome Measure

Acute Kidney Injury (AKI) within the first 72 hours of ICU admission [ Time Frame: Within 72 hours following ICU Admission ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Golisano Children's Hospital at StrongRochesterNew York14642-

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By research site
Golisano Children's Hospital at Strong· Rochester, NY

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