Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI

Acute Kidney Injury Clinical Trial

— Taking Focus 2  

Official title:

Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates With Acute Kidney Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05114057
• Other study ID #: CIN002 - Taking Focus 3
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: November 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Kelli A Krallman, RN, BSN, MS
• Phone: 513-636-4837
• Email: kelli.krallman[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1380
• Est. completion date: July 1, 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis
• Neonatal Sepsis
• Sepsis
• Toxemia
• Wounds and Injuries

Intervention

Other:
• Renal Angina Index (RAI)
Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Decision Support Performance	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)	Days 2-4 after ICU admission
Secondary	Rate of Clinical Decision Support Completion	Time to complete the risk stratification and biomarker testing is less than 48 hours	48 hours