Prospective Validation of AKI Prediction

NCT06804200 | Recruiting

• 2 other identifiers: STUDY00008612K23DK138299
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Machine Learning; Pediatrics; Critical Care

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury (AKI) within the first 72 hours of ICU admission

  Acute Kidney Injury (AKI) defined by KDIGO stages 1, 2, or 3, based on changes in serum creatinine levels or urine output (UOP), assessed within the first 72 hours of ICU admission. Stage 1 is defined by a 1.5 to 1.9 times baseline serum creatinine or an increase of ≥0.3 mg/dL. Stage 2 is a 2.0 to 2.9 times baseline increase, and Stage 3 is a 3.0 times baseline increase or a serum creatinine ≥4.0 mg/dL.

  Within 72 hours following ICU Admission

Secondary Outcomes (2)

• Prediction Accuracy and Timeliness of AKI Risk using a Predictive Model

  Within 12 hours of ICU Admission

• Risk of Mortality in Patients with Acute Kidney Injury (AKI)

  28 Days following ICU admission

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adam C Dziorny: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Golisano Children's Hospital at Strong

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Adam C Dziorny, MD, PhD

CONTACT

585-276-3014; adam_dziorny@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: June 25, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)