Acute Kidney Injury, Acute Kidney Injury Due to Sepsis, Neonatal Sepsis
Conditions
Keywords
Renal Angina Index, NGAL
Brief summary
This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.
Detailed description
In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.
Interventions
OTHERRenal Angina Index (RAI)
Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
Inclusion criteria
* Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution
Exclusion criteria
* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.736m2) * History of kidney transplant within the previous 90 days * Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission * Acute DNR order or clinical team is not committed to escalating medical care * Anticipated to require intensive care for less than 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Decision Support Performance | Days 2-4 after ICU admission | Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinical Decision Support Completion | 48 hours | Time to complete the risk stratification and biomarker testing is less than 48 hours |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStuart L Goldstein, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed