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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK138299 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction Accuracy and Timeliness of AKI Risk using a Predictive Model | Predictive model results generated prospectively (at 12 hours following admission) will be used to generate a 2x2 confusion matrix with prospectively identified AKI by serum creatinine or urine output changes based on KDIGO criteria. Investigators will calculate sensitivity, PPV, and NNA for the prospective identification of AKI. Investigators will report the time of AKI prediction compared to admission date and the onset date of AKI. |
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Inclusion Criteria:
Exclusion Criteria:
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All medical and surgical patients admitted to the pediatric intensive care unit and pediatric cardiac intensive care unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam C Dziorny, MD, PhD | Contact | 585-276-3014 | adam_dziorny@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golisano Children's Hospital at Strong | Recruiting | Rochester | New York | 14642 | United States |
Non-PHI data elements may be made available by request, per data sharing plan.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Within 12 hours of ICU Admission |
| Risk of Mortality in Patients with Acute Kidney Injury (AKI) | Investigators will assess for AKI independent risk of mortality at 28 days after adjusting for confounders. | 28 Days following ICU admission |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |